Trial Outcomes & Findings for Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors (NCT NCT01927341)

NCT ID: NCT01927341

Last Updated: 2021-02-18

Results Overview

DLT was defined as an adverse event or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment (Cycle 1) with binimetinib and panitumumab and met any of the specified criteria.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Within the first 28 days of treatment with binimetinib and panitumumab (Cycle 1)

Results posted on

2021-02-18

Participant Flow

Study had Phase 1b followed by Phase 2. Phase 1b was to evaluate the maximum tolerated dose (MTD)/recommended Phase 2 dose (RPD2) in participants with mutant or wild type (WT) rat sarcoma viral oncogene homologue (RAS) metastatic colorectal cancer (mCRC) who had progressed on or following standard therapy or for whom no standard therapy existed. Phase 2 assessed anti-tumor activity in participants enrolled based on the previous anti-EGFR monoclonal antibody therapy and RAS mutational status.

The study used binimetinib 45 mg twice a day (BID) and panitumumab 6 mg/kg intravenous infusion once every second week without planned dose escalation.

Participant milestones

Participant milestones
Measure	Phase 1b: Binimetinib (MEK162) + Panitumumab Participants received binimetinib 45 milligram (mg) orally twice daily with panitumumab 6 milligram per kilogram (mg/kg) intravenous (IV) infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2:Mutant RAS Epidermal Growth Factor Receptor Inhibitor(EGFRi)-Naive:Binimetinib + Panitumumab Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Phase 1b STARTED	10	0	0	0	0
Phase 1b COMPLETED	0	0	0	0	0
Phase 1b NOT COMPLETED	10	0	0	0	0
Phase 2 STARTED	0	15	5	15	8
Phase 2 COMPLETED	0	0	0	0	0
Phase 2 NOT COMPLETED	0	15	5	15	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Binimetinib (MEK162) + Panitumumab Participants received binimetinib 45 milligram (mg) orally twice daily with panitumumab 6 milligram per kilogram (mg/kg) intravenous (IV) infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2:Mutant RAS Epidermal Growth Factor Receptor Inhibitor(EGFRi)-Naive:Binimetinib + Panitumumab Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Phase 1b Lost to Follow-up	1	0	0	0	0
Phase 1b Death	2	0	0	0	0
Phase 1b Follow-up completed	7	0	0	0	0
Phase 2 Lost to Follow-up	0	1	0	0	0
Phase 2 Participant withdrew consent	0	2	1	2	3
Phase 2 Death	0	4	0	3	2
Phase 2 New cancer therapy	0	1	0	4	1
Phase 2 Disease progression	0	1	1	1	0
Phase 2 Follow-up completed	0	6	3	5	2

Baseline Characteristics

Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Total n=53 Participants Total of all reporting groups
Age, Continuous	54.1 Years STANDARD_DEVIATION 10.6 • n=99 Participants	54.3 Years STANDARD_DEVIATION 11.2 • n=107 Participants	60.2 Years STANDARD_DEVIATION 12.0 • n=206 Participants	59.8 Years STANDARD_DEVIATION 14.0 • n=7 Participants	54.1 Years STANDARD_DEVIATION 10.7 • n=31 Participants	56.4 Years STANDARD_DEVIATION 11.8 • n=30 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	9 Participants n=107 Participants	4 Participants n=206 Participants	9 Participants n=7 Participants	5 Participants n=31 Participants	31 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	6 Participants n=107 Participants	1 Participants n=206 Participants	6 Participants n=7 Participants	3 Participants n=31 Participants	22 Participants n=30 Participants

PRIMARY outcome

Timeframe: Within the first 28 days of treatment with binimetinib and panitumumab (Cycle 1)

Population: Dose determining set included all phase 1b participants who received at least 1 dose of binimetinib or panitumumab and had at least 1 valid post baseline safety assessment, and those who had either experienced a DLT at any time during Cycle 1 or had met the following minimum treatment and safety evaluation requirements without experiencing a DLT during Cycle 1.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Number of Participants With Dose-limiting Toxicities (DLT): Phase 1b	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From the start of the treatment until CR or PR (approximately up to 11 months)

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

ORR: percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as assessed per RECIST version 1.1. BOR: the best response recorded from the start of the treatment until CR or PR. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=15 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment: Phase 2	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	6.7 Percentage of participants Interval 0.2 to 31.9	0 Percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 28 days after last dose of study drug (approximately up to 12 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study drug and had at least 1 valid post-baseline safety assessment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) TEAEs	10 Participants	15 Participants	5 Participants	15 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) SAEs	3 Participants	6 Participants	2 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 28 days after last dose of study drug (approximately up to 12 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study drug and had at least 1 valid post-baseline safety assessment.

Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): greater than or equal to (\>=)180 mmHg or less than equal to (\<=) 90 mmHg with increase or decrease from baseline of \>=20 mmHg with high and low post baseline values; 2) Diastolic blood pressure (DBP) (mmHg): \>=105 mmHg or \<=50 mmHg with increase or decrease from baseline of \>=15 mmHg with high and low post baseline values; 3) Pulse rate in beats per minutes (bpm): \>=120 bpm or \<=50 bpm with increase or decrease from baseline of \>=15 bpm with high and low post baseline values; 4) Weight in kilogram: \>=10% increase or decrease from baseline with high and low post baseline values; 5) Oral body temperature in degree Celsius (C) : \>=39 degree C or \<=35 degree C with high and low post baseline values. Categories, with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Number of Participants With Vital Sign Abnormalities DBP: >=105 mmHg or <=50 mmHg with increase or decrease from baseline of >=15 mmHg: high only	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Oral body temperature: >=39 °C or <=35 °C: low only	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities SBP :>=180 mmHg or <=90 mmHg with increase or decrease from baseline of >=20 mmHg: low only	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Pulse: >=120 bpm or <=50 bpm with increase or decrease from baseline of >=15 bpm: high only	0 Participants	3 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Vital Sign Abnormalities Pulse:>=120 bpm or <=50 bpm with increase or decrease from baseline of >=15 bpm: low only	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Weight: >=10 % increase or decrease from baseline: high only	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Weight: >=10 % increase or decrease from baseline: low only	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Sign Abnormalities Oral body temperature: >=39 °C or <=35 °C: high only	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 28 days after last dose of study drug (approximately up to 12 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study drug and had at least 1 valid post-baseline safety assessment. Here, "number analyzed" signifies participants evaluable at specific rows.

ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (\>) 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 3) Heart rate (bpm): RR decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100; RR (interval between 2 successive R waves on ECG) increase \>25% and to a VR \<50; 4) Pulse rate (msec): increase \>25% and to a value \>200; 5) QT (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 6) QRS (msec): increase \>25% and to a value \>110. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Number of Participants With Electrocardiogram (ECG) Abnormalities QT: increase from baseline >60 msec	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcB: >450 msec	3 Participants	2 Participants	1 Participants	5 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcB: >480 msec	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcB: >500 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcB: Increase from baseline >30 msec	3 Participants	5 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF: >450 msec	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTcF: Increase from baseline >30 msec	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Heart rate: RR decrease >25% and to a VR >100 bpm	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Heart rate: RR increase >25% and to a VR <50 bpm	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QT: >450 msec	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QT: >480 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QT: increase from baseline >30 msec	6 Participants	3 Participants	1 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 28 days after last dose of study drug (approximately up to 12 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study drug and had at least 1 valid post-baseline safety assessment.

Following parameters were analyzed for laboratory examination: hematology (hematocrit, erythrocytes); biochemistry (direct bilirubin, blood urea nitrogen, calcium, creatine kinase, triiodothyronine, thyroxine and thyrotropin). Clinical significance of laboratory abnormalities were judged by investigator.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression (approximately up to 11 months)

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

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment: Phase 1b	0 Percentage of participants Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization to the date of the first documented PD or death (approximately up to 11 months)

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

PFS: time from date of randomization to date of first documented PD or death due to any cause, whichever occurred first. RECIST 1.1, PD:\>=20% increase in sum of diameter of all measured target lesions (TLs), taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of \>=5 mm\^2. Unequivocal progression of existing non-TLs. Appearance of new lesions. With no event at time of analysis cut-off or at start of any new anti-neoplastic therapy, PFS was censored at date of last adequate tumor assessment of complete response (CR), partial response (PR) or stable disease (SD). CR:disappearance of all non-nodal TLs/non TLs, any pathological lymph nodes as TLs/non TLs must have reduction in short axis to \<10 mm. PR:\>=30% decrease in sum of diameter of all TLs, referring baseline sum of diameters. SD:neither sufficient shrinkage to qualify for PR or CR nor increase in lesions qualified for PD. Kaplan-Meier method used for PFS analysis.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment	3.4 Months Interval 1.4 to 5.2	1.7 Months Interval 1.5 to 3.4	1.8 Months Interval 1.6 to 8.2	2.4 Months Interval 1.6 to 3.5	2.1 Months Interval 1.0 to 10.8

SECONDARY outcome

Timeframe: From the first documented occurrence of response (PR or CR) until the date of the first documented PD or death due to the underlying cancer (approximately up to 11 months)

Population: Full analysis set included all participants who received at least 1 full or partial dose of study drug. The outcome was to be analyzed only in confirmed responders, none of the reporting arms had confirmed responders except Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab.

DOR: time from first documented occurrence of response (PR or CR) until date of first documented PD or death due to underlying cancer. RECIST 1.1. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. PD: at least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm\^2. Unequivocal progression of existing non-target lesions. Appearance of new lesions. Participants with no PD and were still alive, were censored at last adequate tumor assessment. Kaplan-Meier method was used for DOR analysis.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=1 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment	—	—	—	5.3 Months Lower and upper limit of confidence interval was not estimable due to low number of participants with an event.	—

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression (approximately up to 11 months)

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

DCR was defined as the percentage of participants with a confirmed BOR of CR, PR, or stable disease (SD). RECIST 1.1, BOR was defined as the best response recorded from the start of the treatment until CR, PR or SD. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2. Unequivocal progression of existing non-target lesions. Appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Disease Control Rate (DCR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment	70.0 Percentage of participants Interval 34.8 to 93.3	13.3 Percentage of participants Interval 1.7 to 40.5	40.0 Percentage of participants Interval 5.3 to 85.3	40.0 Percentage of participants Interval 16.3 to 67.7	37.5 Percentage of participants Interval 8.5 to 75.5

SECONDARY outcome

Timeframe: From the start of treatment to the date of death due to any cause (approximately up to 11 months)

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

OS was defined as the time from the start of treatment to the date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. Kaplan-Meier method was used for OS analysis.

Outcome measures

Outcome measures
Measure	Phase 1b: Binimetinib + Panitumumab n=10 Participants Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 Participants Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 Participants Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 Participants Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Overall Survival (OS)	NA Months Interval 1.9 to Median and lower limit of confidence interval was not estimable due to low number of participants with an event.	3.5 Months Interval 2.1 to 8.0	5.5 Months Interval 3.9 to 9.6	5.8 Months Interval 3.1 to 8.0	11.2 Months Interval 2.1 to 13.3

Adverse Events

Phase 1b: Binimetinib + Panitumumab

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b: Binimetinib + Panitumumab n=10 participants at risk Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 participants at risk Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 participants at risk Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 participants at risk Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 participants at risk Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Cardiac disorders Sinus Tachycardia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Cardiac disorders Tachycardia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Abdominal Distension	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Colitis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Nausea	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Fatigue	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders General Physical Health Deterioration	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Pyrexia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Pneumonia	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Pyelonephritis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Septic Shock	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Skin Infection	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Platelet Count Decreased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Troponin T Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Renal and urinary disorders Acute Kidney Injury	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Renal and urinary disorders Hydronephrosis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Vascular disorders Deep Vein Thrombosis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Vascular disorders Hypovolaemic Shock	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.

Other adverse events

Other adverse events
Measure	Phase 1b: Binimetinib + Panitumumab n=10 participants at risk Participants received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 40 weeks.	Phase 2: Mutant RAS EGFRi-Naive: Binimetinib + Panitumumab n=15 participants at risk Participants with mutant RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 15.4 weeks.	Phase 2: Mutant RAS Anti-EGFRi: Binimetinib + Panitumumab n=5 participants at risk Participants with acquired mutant RAS mCRC who had been pretreated with anti-EGFR monoclonal antibody therapy, but had not been pre-treated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 33.7 weeks.	Phase 2: WT RAS Anti-EGFRi: Binimetinib + Panitumumab n=15 participants at risk Participants with WT RAS mCRC who had been pretreated with an anti-EGFRi monoclonal antibody therapy but had not been pretreated with EGFR tyrosine kinase inhibitor therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 32.1 weeks.	Phase 2: WT RAS EGFRi-Naive: Binimetinib + Panitumumab n=8 participants at risk Participants with WT RAS mCRC who had not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy, received binimetinib 45 mg orally twice daily with panitumumab 6 mg/kg IV infusion once every second week on Days 1 and 15 of every cycle (1 cycle = 28 days) until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. Maximum treatment exposure was approximately of 48.0 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Cardiac disorders Palpitations	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Vision Blurred	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Chorioretinopathy	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Retinal Detachment	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Retinopathy	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Periorbital Oedema	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Vitreous Floaters	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Dry Eye	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Eye Swelling	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Eye Discharge	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Iritis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Eye disorders Visual Impairment	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	70.0% 7/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	60.0% 9/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	100.0% 5/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	86.7% 13/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	50.0% 4/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Vomiting	40.0% 4/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	53.3% 8/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	80.0% 4/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	60.0% 9/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	37.5% 3/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Nausea	50.0% 5/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	53.3% 8/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	80.0% 4/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	62.5% 5/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	80.0% 4/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Stomatitis	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 6/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	37.5% 3/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Constipation	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Dry Mouth	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Dyspepsia	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Oral Pain	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Glossodynia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Flatulence	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Gastrointestinal Inflammation	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Gastrointestinal disorders Rectal Haemorrhage	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Fatigue	90.0% 9/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	62.5% 5/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Chills	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Oedema Peripheral	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Pyrexia	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Asthenia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Feeling Cold	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Face Oedema	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Facial Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Non-Cardiac Chest Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
General disorders Peripheral Swelling	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Paronychia	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Folliculitis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Conjunctivitis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Sepsis	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Urinary Tract Infection	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Rash Pustular	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Skin Infection	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Respiratory Tract Infection	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Septic Shock	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Injury, poisoning and procedural complications Stoma Site Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Injury, poisoning and procedural complications Sunburn	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Blood Creatine Phosphokinase Increased	50.0% 5/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 6/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Aspartate Aminotransferase Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Ejection Fraction Decreased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Blood Creatinine Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Lipase Increased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Alanine Aminotransferase Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Blood Bilirubin Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Weight Decreased	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Amylase Increased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Intraocular Pressure Increased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Troponin Increased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Investigations Haemoglobin Decreased	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypomagnesaemia	60.0% 6/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Decreased Appetite	50.0% 5/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hyponatraemia	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypophosphataemia	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Metabolism and nutrition disorders Hyperkalaemia	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back Pain	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Pain In Extremity	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthropathy	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Muscle Spasms	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Muscular Weakness	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Nervous system disorders Dysgeusia	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Nervous system disorders Neuropathy Peripheral	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Nervous system disorders Retinal Migraine	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Nervous system disorders Somnolence	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Psychiatric disorders Insomnia	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Psychiatric disorders Anxiety	0.00% 0/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Renal and urinary disorders Haematuria	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Renal and urinary disorders Dysuria	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Reproductive system and breast disorders Genital Haemorrhage	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Reproductive system and breast disorders Vaginal Haemorrhage	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dysphonia	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Hiccups	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Productive Cough	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	80.0% 8/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	33.3% 5/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	62.5% 5/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	46.7% 7/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	40.0% 2/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	60.0% 9/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dry Skin	60.0% 6/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	26.7% 4/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	62.5% 5/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	50.0% 5/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	50.0% 4/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Skin Fissures	30.0% 3/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	25.0% 2/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	12.5% 1/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	13.3% 2/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Skin Ulcer	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Hirsutism	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Nail Disorder	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Petechiae	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Swelling Face	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Skin and subcutaneous tissue disorders Trichorrhexis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Vascular disorders Hypertension	20.0% 2/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 3/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Vascular disorders Hypotension	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	6.7% 1/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	20.0% 1/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Vascular disorders Vasculitis	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.
Infections and infestations Fungal Skin Infection	10.0% 1/10 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/5 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/15 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.	0.00% 0/8 • Baseline up to 28 days after last dose of study drug (approximately up to 12 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study drug and had at least 1 valid post-baseline safety assessment.

Additional Information

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Results disclosure agreements

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