Trial Outcomes & Findings for Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (NCT NCT04585815)

Last Updated: 2024-12-17

Results Overview

DLT=AEs in DLT observation period (OP) related to any study intervention:Grade (G)4 neutropenia;thrombocytopenia or anemia;febrile neutropenia;neutropenic infection;G3 thrombocytopenia with bleeding. Any G\>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G\<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by medical therapy (MT), G3 diarrhea that improved to G\<=2 within 72 hrs, G3 skin toxicity that resolved to G\<=1 in \<7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 lab abnormality \[LA\](medical intervention or hospitalization), or any G4 LA;ALT/AST\>3\*ULN (normal at baseline) or \>3\*ULN and doubling baseline (\>ULN at baseline) and associated with total bilirubin(TB) \>2\*ULN;or ALT/AST\>5\*ULN; or TB\>3\*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Day 1 up to Day 28 of Cycle 1

Results posted on

2024-12-17

Participant Flow

Sub-study A (SSA) was planned to be conducted in 2 parts: Phase 1b and Phase 2. Due to a business decision, Phase 2 was not initiated, hence no participants were enrolled for Phase 2 of SSA. Sub-study B (SSB) was conducted in 2 parts: Phase 1b and Phase 2.

57 participants signed informed consent and 34 participants were enrolled in the study. Of these 34 participants, 13 were enrolled in Sub-study A and 21 in Sub-study B (9 in Phase 1b and 12 in Phase 2). Data is reported at Primary Completion Date (PCD) for Sub-study A and B.

Participant milestones

Participant milestones
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.	Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to \[\>=\]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Sub-study A- Treatment Phase STARTED	4	9	0	0	0	0	0
Sub-study A- Treatment Phase COMPLETED	0	0	0	0	0	0	0
Sub-study A- Treatment Phase NOT COMPLETED	4	9	0	0	0	0	0
Sub-study A- Follow-up Phase STARTED	0	1	0	0	0	0	0
Sub-study A- Follow-up Phase COMPLETED	0	0	0	0	0	0	0
Sub-study A- Follow-up Phase NOT COMPLETED	0	1	0	0	0	0	0
Sub-study B- Treatment Phase STARTED	0	0	3	6	3	2	7
Sub-study B- Treatment Phase COMPLETED	0	0	0	0	0	0	0
Sub-study B- Treatment Phase NOT COMPLETED	0	0	3	6	3	2	7
Sub-study B- Follow-up Phase STARTED	0	0	2	3	1	1	4
Sub-study B- Follow-up Phase COMPLETED	0	0	1	0	0	0	0
Sub-study B- Follow-up Phase NOT COMPLETED	0	0	1	3	1	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.	Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to \[\>=\]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Sub-study A- Treatment Phase Adverse Event	0	1	0	0	0	0	0
Sub-study A- Treatment Phase Death	0	1	0	0	0	0	0
Sub-study A- Treatment Phase Withdrawal by Subject	1	0	0	0	0	0	0
Sub-study A- Treatment Phase Global deterioration of health status	0	1	0	0	0	0	0
Sub-study A- Treatment Phase Other	1	0	0	0	0	0	0
Sub-study A- Treatment Phase Ongoing treatment	2	6	0	0	0	0	0
Sub-study A- Follow-up Phase Ongoing in study	0	1	0	0	0	0	0
Sub-study B- Treatment Phase Adverse Event	0	0	0	0	0	0	2
Sub-study B- Treatment Phase Death	0	0	0	1	0	0	0
Sub-study B- Treatment Phase Withdrawal by Subject	0	0	0	1	0	1	0
Sub-study B- Treatment Phase Global deterioration of health status	0	0	0	1	0	0	0
Sub-study B- Treatment Phase Ongoing treatment	0	0	0	0	0	0	1
Sub-study B- Treatment Phase Progressive disease	0	0	3	2	2	0	4
Sub-study B- Treatment Phase Physician Decision	0	0	0	1	1	1	0
Sub-study B- Follow-up Phase Ongoing in study	0	0	0	0	1	1	3
Sub-study B- Follow-up Phase Death	0	0	1	3	0	0	1

Baseline Characteristics

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) n=3 Participants Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.	Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) n=6 Participants Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=3 Participants Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=2 Participants Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to \[\>=\]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants	13 Participants n=24 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	21 Participants n=24 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	22 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	32 Participants n=24 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	7 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants	23 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 28 of Cycle 1

Population: DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in Phase 1b and either experienced DLT during the DLT-observation period or completed the DLT-observation period without DLT.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)	0 Percentage of participants	22.2 Percentage of participants	—

PRIMARY outcome

Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Durable ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 millimeter \[mm\]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 up to Day 21 of Cycle 1

DLT=AEs in DLT OP related to any study intervention: G4 neutropenia; thrombocytopenia or anemia; neutropenia; neutropenic infection; G3 thrombocytopenia with bleeding. Any G\>=3 toxicity (except transient G3 fatigue, local reactions/headache that resolved to G\<=1/baseline; G3 nausea, vomiting controlled within 72 hrs, G3 hypertension controlled by MT, G3 diarrhea that improved to G\<=2 within 72 hrs, G3 skin toxicity that resolved to G\<=1 in \<7 days after MT, G3 endocrinopathies controlled by MT and tumors flare); Non-hematologic G3 LA (medical intervention or hospitalization), or any G4 LA;ALT/AST\>3\*ULN (normal at baseline) or \>3\*ULN and doubling baseline (\>ULN at baseline) and associated with TB \>2\*ULN; or ALT/AST\>5\*ULN; or TB\>3\*ULN. Missing 75% of planned doses during DLT OP due to treatment-related toxicities. AE not listed/DLT criteria outside DLT OP was DLT at discretion of sponsor and investigator.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Percentage of Participants With DLT	0 Percentage of participants	1 Percentage of participants	—

PRIMARY outcome

Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 millimeter \[mm\]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 Sub-Study B: Objective Response Rate	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 84.2	14.3 Percentage of participants Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs will be graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were planned to be graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (approximately 44 months)

Following assessments will be performed: hematology: hemoglobin, platelet count, white blood cell (WBC) count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils. Chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate or carbon dioxide (CO2), C-reactive protein (CRP), alkaline phosphatase, sodium, potassium, magnesium chloride, total calcium, total bilirubin, total protein, blood urea nitrogen (BUN) or urea, creatinine, creatinine clearance, uric acid, glucose (random), lactate dehydrogenase, albumin, phosphorus or phosphate, amylase, lipase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Hematology and clinical chemistry parameters were planned to be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (approximately 44 months)

Durable ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, lasting for at least 10 months from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment until the date of the first documentation of PD (approximately 44 months)

Objective response rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment until the date of the first documentation of PD

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Objective response (OR) rate is defined as percentage of participants with confirmed best overall response of CR or PR according to RECIST v1.1 from the date of first dose of study treatment until the date of the first documentation of PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first documentation of OR to the date of the first documentation of PD or death due to any cause, whichever occurred first

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

DR was defined for participants with confirmed OR as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no \<4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of objective response

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

TTR is defined for participants with confirmed objective response as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

PFS is defined as the time from the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first. PD=20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of death due to any cause or censoring date

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

OS is defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were planned to be censored at the date of last contact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 168 hours [Day 8] and 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days)

Population: Pharmacokinetic (PK) parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

AUCtau was defined as area under the plasma concentration time curve from time zero to the next dose.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=7 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab	12500 Micrograms*hour per milliliter Geometric Coefficient of Variation 65	24850 Micrograms*hour per milliliter Geometric Coefficient of Variation 17	—

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) (1 cycle= 28 days)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 168 hours [Day 8],336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab Cycle 1	29.49 Micrograms per milliliter Geometric Coefficient of Variation 55	45.04 Micrograms per milliliter Geometric Coefficient of Variation 38	—
Phase 1b of Sub-Study A: Maximum Observed Plasma Concentration (Cmax) of Sasanlimab Cycle 5	64.60 Micrograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated as a single participant was analyzed.	70.90 Micrograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated as a single participant was analyzed.	—

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 168 hours [Day 8], 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 (pre-dose on Day 1 and 168 hours [Day 8] post dose) (1 cycle= 28 days)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab Cycle 1	164 Hour Interval 144.0 to 168.0	209 Hour Interval 143.0 to 359.0	—
Phase 1b of Sub-Study A: Time for Cmax (Tmax) of Sasanlimab Cycle 5	168 Hour Interval 168.0 to 168.0	162 Hour Interval 162.0 to 162.0	—

SECONDARY outcome

Timeframe: Cycle 1 (pre-dose on Day 1, 336 hours [Day 15] and Day 28 post-dose) and Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab	37.97 Microgram per milliliter Geometric Coefficient of Variation 20	40.24 Microgram per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	—

SECONDARY outcome

Timeframe: Cycle 5 Day 1 (pre-dose) (1 cycle= 28 days)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose) of Cycle 1, 2 and 5; Day 15 of Cycle 1 (1 cycle= 28 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. For 'Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg)' arm, samples were not analyzed for Cycle 2 Day 1 as it was collected incorrectly due to time deviation for visits.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Ctrough of Encorafenib Cycle 1 Day 1	NA Nanograms per milliliter Geometric Coefficient of Variation NA Data could not be calculated as values were below lower limit of quantification.	NA Nanograms per milliliter Geometric Coefficient of Variation NA Data could not be calculated as values were below lower limit of quantification.	—
Phase 1b of Sub-Study A: Ctrough of Encorafenib Cycle 1 Day 15	12.2 Nanograms per milliliter Geometric Coefficient of Variation 176	18.5 Nanograms per milliliter Geometric Coefficient of Variation 50	—
Phase 1b of Sub-Study A: Ctrough of Encorafenib Cycle 2 Day 1	—	11.1 Nanograms per milliliter Geometric Coefficient of Variation 204	—
Phase 1b of Sub-Study A: Ctrough of Encorafenib Cycle 5 Day 1	5.0 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated for single participant	7.8 Nanograms per milliliter Geometric Coefficient of Variation 191	—

SECONDARY outcome

Timeframe: Cycle 5 Day 1 (pre-dose)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose) of Cycles 1, 2, and 5 (1 cycle= 28 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Overall Number Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=1 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=4 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Ctrough of Binimetinib Cycle 2 Day 1	19.2 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	40.9 Nanograms per milliliter Geometric Coefficient of Variation 98	—
Phase 1b of Sub-Study A: Ctrough of Binimetinib Cycle 5 Day 1	—	35.7 Nanograms per milliliter Geometric Coefficient of Variation 67	—

SECONDARY outcome

Timeframe: Cycle 5 Day 1 (pre-dose)

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 255 days) (1 cycle= 28 days)

Population: Immunogenicity analysis set was a subset of the safety analysis set (participants who received at least 1 dose of study drug) and included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. All participants included in 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluated for ADA and NAb respectively.

In this outcome measure, number of ADA-positive and NAb-positive participants has been presented. A participant was considered ADA (or 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 \>= \[4-fold dilution increase\] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in \>= 1 post-treatment sample (treatment-boosted).

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab ADA	0 Participants	1 Participants	—
Phase 1b of Sub-Study A: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against Sasanlimab NAb	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 until end of treatment

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment until the date of the first documentation of PD

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and no data was collected.

OR rate is defined as percentage of participants with CR or PR according to RECIST v1.1 based on investigator assessment. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. OR by PD-L1 expression at baseline was planned to be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to end of treatment

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and there was no data collection for it.

EORTC QLQ-C30: consisted of 30 questions grouped into 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and financial impact. All scales and single item measures ranged in score from 0 to 100. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the symptom scales and single items represent a greater presence of symptoms or financial impact.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to end of treatment

Population: Due to a business decision, no participant was enrolled in Phase 2 of sub-study A. Hence, Phase 2 was not initiated and there was no data collection for it.

The EORTC QLQ-LC13 is the lung cancer specific module of the EORTC Quality of Life Questionnaire. The EORTC QLQ-LC13 consisted of 13 questions which included 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The item scale ranged from 1 to 4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm was applied to convert to a 0 to 100 point scale where 100 is best quality of life (QOL), for comparability. Higher scores are reflective of a greater presence of symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 1	0 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 2	1 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 3	2 Participants	4 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 4	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 5	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs were graded by the investigator according to NCI CTCAE version 5.0; where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and Grade 5=death

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 3	2 Participants	2 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 1	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 2	0 Participants	0 Participants	2 Participants
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 4	1 Participants	0 Participants	3 Participants
Phase 2 of Sub-Study B: Number of Participants With Adverse Events Graded According to NCI-CTCAE Version 5.0 Grade 5	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Hematology parameters included: anemia, lymphocyte count decreased, platelet count decreased, white blood cell decreased. Number of participants with shift from baseline in hematology parameters by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) were reported. Grade 0= any shift, Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Categories with at least 1 non-zero data values showing shift in Grade from baseline to post-baseline were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Anemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 0 (at baseline) to Grade 3 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 0 (at baseline) to Grade 4 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 1 (at baseline) to Grade 2 (at post baseline)	2 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Platelet count decreased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 White blood cell decreased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Chemistry parameters included: alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, aspartate aminotransferase (AST) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperkalemia, hypoalbuminemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Number of participants with shift from baseline in chemistry parameters by grades as per CTCAE version 5.0 were reported. Grade 0= any shift, Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Categories with at least 1 non-zero data values showing shift in Grade from baseline to post-baseline were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALT increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	2 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 AST increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoalbuminemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Serum amylase increased: Grade 1 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALT increased: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALP increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	2 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALP increased: Grade 1 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 AST increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	2 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 1 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Creatinine increased: Grade 1 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypercalcemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	2 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyperkalemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoalbuminemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoalbuminemia: Grade 1 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoglycemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypokalemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	2 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypomagnesemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyponatremia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	2 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Lipase increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	2 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Serum amylase increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Hematology parameters included: anemia, hemoglobin increased, lymphocyte count decreased, Neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with shift from baseline in hematology parameters by grades as per CTCAE version 5.0 were reported. Grade 0= any shift, Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Categories with at least 1 non-zero data values showing shift in Grade from baseline to post-baseline were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Anemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 2 (at baseline) to Grade 4 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 WBC decreased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	2 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 WBC decreased: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Hemoglobin increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 1 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Lymphocyte count decreased: Grade 1 (at baseline) to Grade 3 (at post baseline)	1 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Neutrophil count decreased: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Hematology Parameter Values Based on CTCAE V5.0 Platelet count decreased: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the start of study treatment (Cycle1 Day1) up to 30 days after last dose of study treatment (maximum of 21 months)

Population: Safety analysis set included all participants who received at least 1 dose of study drug.

Chemistry parameters included: ALT increased, ALP increased, AST increased, blood bilirubin increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased, serum amylase increased. Number of participants with shift from baseline in chemistry parameters by grades as per CTCAE version 5.0 were reported. Grade 0= any shift, Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Categories with at least 1 non-zero data values showing shift in Grade from baseline to post-baseline were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALP increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	2 Participants	1 Participants	2 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 AST increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Blood bilirubin increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Creatinine increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Creatinine increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypermagnesemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoalbuminemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	2 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypocalcemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyponatremia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALT increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	3 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 ALT increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 AST increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	4 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Blood bilirubin increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 1 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Chronic kidney disease: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypercalcemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyperkalemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	1 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyperkalemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypernatremia: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypoalbuminemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypokalemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	1 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypokalemia: Grade 0 (at baseline) to Grade 3 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypomagnesemia: Grade 0 (at baseline) to Grade 1 (at post baseline)	0 Participants	0 Participants	4 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hypomagnesemia: Grade 0 (at baseline) to Grade 2 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyponatremia: Grade 0 (at baseline) to Grade 3 (at post baseline)	0 Participants	0 Participants	2 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Hyponatremia: Grade 1 (at baseline) to Grade 3 (at post baseline)	0 Participants	1 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Lipase increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	2 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Lipase increased: Grade 0 (at baseline) to Grade 2 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Lipase increased: Grade 0 (at baseline) to Grade 3 (at post baseline)	0 Participants	0 Participants	1 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Serum amylase increased: Grade 0 (at baseline) to Grade 1 (at post baseline)	1 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Shift From Baseline in Chemistry Parameter Values Based on CTCAE V5.0 Serum amylase increased: Grade 2 (at baseline) to Grade 3 (at post baseline)	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurred first (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Two sided 95% CI was based on Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Objective Response Rate (ORR)	0.0 Percentage of participants Interval 0.0 to 70.8	0.0 Percentage of participants Interval 0.0 to 45.9	—

SECONDARY outcome

Timeframe: From the date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)

Population: Data was not estimable due to insufficient number of participants (with events) evaluable for this outcome measure.

DR was defined for participants with confirmed objective response (OR) as time from date of first documentation of OR to the date of first documentation of PD or death (any cause), whichever occurred first. OR=CR or PR according to RECIST v1.1 based on investigator assessment. CR and PR must be confirmed by repeat assessments performed no \<4 weeks after criteria for response were first met. CR=complete disappearance of all target lesions (TLs) with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions (TMLs). PD=20% increase in sum of diameters of TMLs above smallest sum observed (over baseline if no decrease in sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)

Population: Data was not estimable due to insufficient number of participants (with events) evaluable for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=5 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Progression-Free Survival (PFS)	3.6 Months Interval 0.7 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with event.	6.5 Months Interval 3.6 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with event.	—

SECONDARY outcome

Timeframe: From date of first documentation of OR to the date of first documentation of PD or death, whichever occurred first (maximum of 21 months)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=1 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=1 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Duration of Response (DR)	NA Months Median and 95% CI could not be calculated as the only participant analyzed did not have an event of interest.	—	5.8 Months 95% CI could not be calculated as only one participant was analyzed, who experienced an event of interest.

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for ''Phase 2 of SSB: 1L NSCLC / PD-L1: TPS \>=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg)'' was not estimable due to insufficient number of participants (with events) evaluable for this outcome measure.

TTR is defined for participants with confirmed OR as the time from the date of first dose of study treatment to the date of first documentation of objective response (CR or PR) which was subsequently confirmed. CR=complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR=greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=1 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=1 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Time to Tumor Response (TTR)	4.1 Months Interval 4.1 to 4.1	—	1.4 Months Interval 1.4 to 1.4

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of first documentation of PD or death due to any cause, whichever occurred first (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Progression-Free Survival (PFS)	4.2 Months Interval 4.0 to Upper limit of 95% CI could not be calculated due to insufficient participants with event.	NA Months Median and 95% CI could not be calculated due to insufficient participants with event.	4.0 Months Interval 1.4 to 4.2

SECONDARY outcome

Timeframe: From the date of first dose of study treatment to the date of death due to any cause or censoring date, whichever occurred first (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Overall Survival (OS)	NA Months Median and 95% CI could not be calculated due to insufficient participants with event.	NA Months Median and 95% CI could not be calculated due to insufficient participants with event.	4.0 Months Upper and lower limits of 95% CI could not be calculated due to insufficient participants with event.

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug (i.e., sasanlimab). Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=3 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Cmax of Sasanlimab Cycle 1	8840 Nanograms per milliliter Geometric Coefficient of Variation 127	11570 Nanograms per milliliter Geometric Coefficient of Variation 79	—
Phase 1b of Sub-Study B: Cmax of Sasanlimab Cycle 5	23080 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	47340 Nanograms per milliliter Geometric Coefficient of Variation 42	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, ''Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed date to the table. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=5 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Cmax of Axitinib Cycle 1 Day 1	5.094 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	22.81 Nanograms per milliliter Geometric Coefficient of Variation 80	—
Phase 1b of Sub-Study B: Cmax of Axitinib Cycle 1 Day 8	3.440 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	13.74 Nanograms per milliliter Geometric Coefficient of Variation 106	—
Phase 1b of Sub-Study B: Cmax of Axitinib Cycle 5 Day 1	—	33.79 Nanograms per milliliter Geometric Coefficient of Variation 73	—
Phase 1b of Sub-Study B: Cmax of Axitinib Cycle 5 Day 8	13.10 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	24.85 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. ''Number of Participants Analyzed'': participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable at specified timepoints. Data for only those participants who received SEA-TGT were planned to be reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=5 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Cmax of SEA-TGT Cycle 1	42550 Nanograms per milliliter Geometric Coefficient of Variation 109	—	—
Phase 1b of Sub-Study B: Cmax of SEA-TGT Cycle 5	32660 Nanograms per milliliter Geometric Coefficient of Variation 17	—	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Cmax of Sasanlimab Cycle 5	—	43500 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	20600 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.
Phase 2 of Sub-Study B: Cmax of Sasanlimab Cycle 1	11780 Nanograms per milliliter Geometric Coefficient of Variation 45	13810 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	10350 Nanograms per milliliter Geometric Coefficient of Variation 45

SECONDARY outcome

Timeframe: Cycle 1: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1; Cycle 5: pre-dose on Day 1, Day 8 and 3 hours post-dose on Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=6 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Cmax of Axitinib Cycle 1 Day 1	37.43 Nanograms per milliliter Geometric Coefficient of Variation 85	18.23 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	11.18 Nanograms per milliliter Geometric Coefficient of Variation 112
Phase 2 of Sub-Study B: Cmax of Axitinib Cycle 1 Day 8	39.50 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	2.360 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	2.708 Nanograms per milliliter Geometric Coefficient of Variation 132
Phase 2 of Sub-Study B: Cmax of Axitinib Cycle 5 Day 1	—	11.10 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	7.710 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, 168 hours post-dose on Day 1, Cycle 5: pre-dose, 168 hours post-dose on Day 1 (1 cycle= 21 days)

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Cmax of SEA-TGT Cycle 1	36970 Nanograms per milliliter Geometric Coefficient of Variation 36	35500 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	30590 Nanograms per milliliter Geometric Coefficient of Variation 39
Phase 2 of Sub-Study B: Cmax of SEA-TGT Cycle 5	—	43000 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	44900 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and Cycle 5 Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=2 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=4 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab Cycle 5	23000 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	23170 Nanograms per milliliter Geometric Coefficient of Variation 29	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=1 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=3 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib Cycle 1 Day 8	3.440 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	13.74 Nanograms per milliliter Geometric Coefficient of Variation 106	—
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib Cycle 5 Day 1	—	29.42 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	—
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib Cycle 5 Day 8	13.10 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	24.85 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters measured. 'Number of Participants Analyzed': participants evaluable for this outcome measure, 'Number Analyzed': participants evaluable at specified timepoints. Data for only those participants who received SEA-TGT were planned to be reported hence Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) arm was not reported.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT Cycle 5	4813 Nanograms per milliliter Geometric Coefficient of Variation 35	—	—

SECONDARY outcome

Timeframe: Cycle 1: pre-dose on Day 1, Cycle 5: pre-dose on Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. 'Number of Participants Analyzed': participants with evaluable data for this outcome measure and 'Number Analyzed': participants evaluable at specified time points. This outcome measure was not applicable for participants of ''Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%''

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=1 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=2 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab Cycle 1	—	—	87.01 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Sasanlimab Cycle 5	—	30400 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	20000 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 and Day 8; pre-dose on Cycle 5 Day 1 and Day 8 (1 cycle= 21 days)

Population: PK parameter analysis set was subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=1 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=1 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=4 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib Cycle 1 Day 8	39.50 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	2.360 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	2.708 Nanograms per milliliter Geometric Coefficient of Variation 132
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of Axitinib Cycle 5 Day 1	—	—	3.630 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1; pre-dose on Cycle 5 Day 1 (1 cycle= 21 days)

Population: PK parameter analysis set: subset of safety analysis set (participants who received at least 1 dose of study drug) with participants who had at least 1 of PK parameters of interest for measured analytes related to study drug. Here 'Number of Participants Analyzed': participants evaluable for this outcome measure and 'Number Analyzed': participants evaluable at specified time points. This outcome measure was not applicable for participants of ''Phase 2 of SSB: 1L NSCLC / PD-L1: TPS 1-49%''

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=1 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=2 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT Cycle 1	—	55.00 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	24.47 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as at least 3 values were required and this criterion could not be fulfilled due to lack of available data.
Phase 2 of Sub-Study B: Pre-dose Concentration During Multiple Dosing (Ctrough) of SEA-TGT Cycle 5	—	5770 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.	8490 Nanograms per milliliter Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated for single participant.

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)

Population: Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample. Here ''Number analyzed'' signifies number of participants with at least one post-treatment ADA result for respective category.

A participant was considered ADA (or 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 \>= \[4-fold dilution increase\] in titer (equivalent to 0.602 unit increase in logarithm to base 10 (log10) titer from baseline in \>= 1 post-treatment sample (treatment-boosted).

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=6 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ADA against sasanlimab	0 Participants	1 Participants	—
Phase 1b of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ADA against SEA-TGT	—	0 Participants	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1 until end of treatment (up to approximately 21 months) (1 cycle= 21 days)

Population: Immunogenicity analysis set included participants who had at least 1 analyzed sasanlimab ADA/NAb sample.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ADA against sasanlimab	0 Participants	0 Participants	0 Participants
Phase 2 of Sub-Study B: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Sasanlimab and SEA-TGT ADA against SEA-TGT	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)

Population: Full analysis set included all participants who received at least 1 dose of study drug.

ORR was defined as percentage of participants with confirmed CR or PR according to RECIST v1.1 based on investigator assessment, from the date of first CR or PR until the date of the first documentation of disease progression (PD), death, or start of new anticancer therapy. CR was defined as complete disappearance of all target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 millimeter \[mm\]). PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome measures
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=3 Participants Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=2 Participants Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 Participants Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Phase 2 of Sub-Study B: Objective Response Rate by PD-L1 Expression in Available Tumor Tissue	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 84.2	14.3 Percentage of participants Interval 0.4 to 57.9

Adverse Events

Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 1 deaths

Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 participants at risk Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 participants at risk Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) n=3 participants at risk Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.	Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) n=6 participants at risk Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=3 participants at risk Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=2 participants at risk Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to \[\>=\]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 participants at risk Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
General disorders Chest pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Pyrexia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Hepatobiliary disorders Hepatitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Immune system disorders Anaphylactic shock	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations COVID-19	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Diverticulitis	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Lower respiratory tract infection	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Pneumonia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Haematuria	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Ureterolithiasis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Cardiac disorders Angina pectoris	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Cardiac disorders Bradycardia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Enteritis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Colitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Sepsis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Septic shock	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood creatinine increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Headache	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Syncope	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Hypertension	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Hypotension	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.

Other adverse events

Other adverse events
Measure	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (300mg) + Binimetinib (45mg) n=4 participants at risk Participants with non-small cell lung cancer (NSCLC) with BRAFV600 mutations were administered a single dose of sasanlimab 300 milligrams (mg) subcutaneously on Day 1 of each cycle along with once daily (QD) oral dose of 300 mg encorafenib and twice daily (BID) oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSA: Sasanlimab (300mg) + Encorafenib (450mg) + Binimetinib (45mg) n=9 participants at risk Participants with NSCLC with BRAFV600 mutations were administered a single dose of sasanlimab 300 mg subcutaneously on Day 1 of each cycle along with QD oral dose of 450 mg encorafenib and BID oral dose of 45 mg binimetinib during each 28-day cycle.	Phase 1b of SSB: Sasanlimab (225 mg) + Axitinib (5 mg) n=3 participants at risk Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg every 3 weeks (Q3W) subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle during each 21-day cycle.	Phase 1b of SSB: Sasanlimab (225mg) + Axitinib (5 mg) + SEA-TGT(1mg/kg) n=6 participants at risk Participants with NSCLC and who received any line of therapy for advanced/metastatic NSCLC were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W intravenous (IV) infusion of 1 milligram per kilogram (mg/kg) SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC PD-L1: TPS 1-49% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=3 participants at risk Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with low programmed death ligand - 1 (PD-L1) levels Tumor proportion score (TPS)-49 percent (%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA-TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 1L NSCLC / PD-L1: TPS >=50% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=2 participants at risk Participants with NSCLC with who were treatment-naïve for advanced/metastatic disease with high PD-L1 (TPS greater than or equal to \[\>=\]50%) were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and Q3W IV infusion of 1 mg/kg SEA+ TGT on Day 1 of each cycle during each 21-day cycle.	Phase 2 of SSB: 2/3L NSCLC / PD-L1: TPS >=1% (Saslimab (225mg)+Axitinib (5mg)+SEA-TGT (1mg/kg) n=7 participants at risk Participants with NSCLC who received 1 or 2 lines of therapy for advanced/metastatic NSCLC and whose disease has progressed on prior PD-1/ PD-L1 therapy and who have PD-L1 TPS \>= 1% were administered a single dose of sasanlimab 225 mg Q3W subcutaneously along with BID oral dose of 5 mg axitinib on Day 1 of each cycle and 1 mg/kg IV infusion Q3W SEA-TGT on Day 1 of each cycle during each 21-day cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	100.0% 3/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Ear and labyrinth disorders Tinnitus	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Endocrine disorders Hypothyroidism	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Macular oedema	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Ocular discomfort	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Retinal fovea disorder	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Vision blurred	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 3/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Abdominal pain lower	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Constipation	50.0% 2/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 3/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 3/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	42.9% 3/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Gastritis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Nausea	50.0% 2/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	42.9% 3/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Tooth discolouration	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Chest pain	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Chills	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Fatigue	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 3/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 3/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	42.9% 3/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Oedema peripheral	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Peripheral swelling	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Pyrexia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	44.4% 4/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Acne pustular	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations COVID-19	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Lower respiratory tract infection	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Rash pustular	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Alanine aminotransferase increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	100.0% 3/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 3/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood creatinine increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Gamma-glutamyltransferase increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Glomerular filtration rate decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Lipase increased	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyperphosphataemia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	55.6% 5/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Dizziness	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Dysgeusia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Headache	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Paraesthesia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Presyncope	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Restless legs syndrome	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Pollakiuria	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Ureterolithiasis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 3/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Purpura	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 4/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Skin tightness	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Hot flush	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Hypertension	25.0% 1/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 3/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Phlebitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Vomiting	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	22.2% 2/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Endocrine disorders Hyperthyroidism	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Dry eye	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Uveitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Eye disorders Vitreous floaters	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Mouth ulceration	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Odynophagia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Oral pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Gastrointestinal disorders Visceral venous thrombosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Asthenia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Catheter site hypersensitivity	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Malaise	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
General disorders Pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Hepatobiliary disorders Hepatitis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Candida infection	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Herpes zoster	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Pharyngitis streptococcal	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Infections and infestations Urinary tract infection	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	— 0/0 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	100.0% 2/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Amylase increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood albumin decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood bicarbonate decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood bilirubin increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood corticotrophin increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood creatine increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations C-reactive protein increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Electrocardiogram T wave inversion	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Haemoglobin decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations International normalised ratio increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	11.1% 1/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Lymphocyte count decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	100.0% 3/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Neutrophil count decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Platelet count decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Troponin I increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Troponin increased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Weight decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations White blood cell count decreased	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 2/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Nervous system disorders Neuralgia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Psychiatric disorders Insomnia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Glycosuria	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Renal and urinary disorders Proteinuria	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 3/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	28.6% 2/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	66.7% 2/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	57.1% 4/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Granuloma annulare	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Embolism	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Hypotension	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	50.0% 1/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	14.3% 1/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Vascular disorders Thrombosis	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Alanine aminotransferase	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Aspartate aminotransferase	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	16.7% 1/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Investigations Blood lactate dehydrogenase	0.00% 0/4 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/9 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	33.3% 1/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/6 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/3 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/2 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.	0.00% 0/7 • From the start of study treatment (Cycle1 Day1) up to approximately 19 months for SSA and From the start of study treatment (Cycle1 Day1) up to approximately 21 months for SSB Same event may appear as both non-serious adverse event (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.

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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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