Trial Outcomes & Findings for Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) (NCT NCT02603419)

Last Updated: 2020-04-24

Results Overview

Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Day 2 of Cycle 1

Results posted on

2020-04-24

Participant Flow

Study was conducted in 2 phases: lead-in and expansion. Expansion phase was terminated by the sponsor on 30 April 2018.

Participant milestones

Participant milestones
Measure	Lead-in Phase: Avelumab 70 mg Q2W Participants with relapsed/refractory Classical Hodgkins Lymphoma (cHL) received an intravenous (IV) infusion of 70 milligrams (mg) of avelumab, every two weeks (Q2W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, every 3 weeks (Q3W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 milligrams/kilogram (mg/kg) of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.	Expansion Phase: Avelumab 70 mg, 500 mg Q2W All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a complete response (CR) at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a partial response (PR) at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a stable disease (SD) at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
Lead-in Phase:Maximum Exposure:123Weeks STARTED	6	7	6	6	6	0
Lead-in Phase:Maximum Exposure:123Weeks Treated	6	6	6	6	6	0
Lead-in Phase:Maximum Exposure:123Weeks COMPLETED	0	0	0	0	0	0
Lead-in Phase:Maximum Exposure:123Weeks NOT COMPLETED	6	7	6	6	6	0
Expansion Phase:Maximum Exposure:48Weeks STARTED	0	0	0	0	0	3
Expansion Phase:Maximum Exposure:48Weeks COMPLETED	0	0	0	0	0	0
Expansion Phase:Maximum Exposure:48Weeks NOT COMPLETED	0	0	0	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lead-in Phase: Avelumab 70 mg Q2W Participants with relapsed/refractory Classical Hodgkins Lymphoma (cHL) received an intravenous (IV) infusion of 70 milligrams (mg) of avelumab, every two weeks (Q2W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, every 3 weeks (Q3W) until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 milligrams/kilogram (mg/kg) of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.	Expansion Phase: Avelumab 70 mg, 500 mg Q2W All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a complete response (CR) at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a partial response (PR) at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a stable disease (SD) at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
Lead-in Phase:Maximum Exposure:123Weeks Death	0	1	0	0	0	0
Lead-in Phase:Maximum Exposure:123Weeks Progressive Disease	2	4	2	4	3	0
Lead-in Phase:Maximum Exposure:123Weeks Adverse Event	2	0	3	0	1	0
Lead-in Phase:Maximum Exposure:123Weeks Physician Decision	0	0	0	0	1	0
Lead-in Phase:Maximum Exposure:123Weeks No Longer Meets Eligibility Criteria	0	1	0	0	0	0
Lead-in Phase:Maximum Exposure:123Weeks Other	2	1	1	0	1	0
Lead-in Phase:Maximum Exposure:123Weeks Withdrawal by Subject	0	0	0	2	0	0
Expansion Phase:Maximum Exposure:48Weeks Lost to Follow-up	0	0	0	0	0	1
Expansion Phase:Maximum Exposure:48Weeks Death	0	0	0	0	0	1
Expansion Phase:Maximum Exposure:48Weeks Withdrawal by Subject	0	0	0	0	0	1

Baseline Characteristics

Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=7 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.	Expansion Phase: Avelumab 70 mg, 500 mg Q2W n=3 Participants All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	28 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=8 Participants	25 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	31 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	26 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 2 of Cycle 1

Population: The Target Occupancy (TO) analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose.

Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 2 of Cycle 1	99.5 percentage of occupancy Geometric Coefficient of Variation 0.01	97.7 percentage of occupancy Geometric Coefficient of Variation 0.02	97.6 percentage of occupancy Geometric Coefficient of Variation 0.03	99.7 percentage of occupancy Geometric Coefficient of Variation 0.00	97.8 percentage of occupancy Geometric Coefficient of Variation 0.03

PRIMARY outcome

Timeframe: Day 1 of Cycle 2

Population: The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 1 of Cycle 2	96.3 percentage of occupancy Geometric Coefficient of Variation 0.04	96.2 percentage of occupancy Geometric Coefficient of Variation 0.08	97.0 percentage of occupancy Geometric Coefficient of Variation 0.04	97.3 percentage of occupancy Geometric Coefficient of Variation 0.05	98.8 percentage of occupancy Geometric Coefficient of Variation 0.02

PRIMARY outcome

Timeframe: Day 2 of Cycle 1

Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 2 of Cycle 1	99.0 percentage of occupancy Geometric Coefficient of Variation 0.01	99.0 percentage of occupancy Geometric Coefficient of Variation 0.02	96.8 percentage of occupancy Geometric Coefficient of Variation 0.05	99.7 percentage of occupancy Geometric Coefficient of Variation 0.01	89.8 percentage of occupancy Geometric Coefficient of Variation 0.22

PRIMARY outcome

Timeframe: Day 1 of Cycle 2

Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 1 of Cycle 2	81.7 percentage of occupancy Standard Deviation 0.37	91.9 percentage of occupancy Standard Deviation 0.14	99.1 percentage of occupancy Standard Deviation 0.02	99.7 percentage of occupancy Standard Deviation 0.01	98.7 percentage of occupancy Standard Deviation 0.01

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Single Dose	1933 hr*mcg/mL Geometric Coefficient of Variation 64	8450 hr*mcg/mL Geometric Coefficient of Variation 28	15392 hr*mcg/mL Geometric Coefficient of Variation 27	15436 hr*mcg/mL Geometric Coefficient of Variation 38	23780 hr*mcg/mL Geometric Coefficient of Variation 54

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after multiple dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Multiple Dose	2067 hr*mcg/mL Geometric Coefficient of Variation 6	8789 hr*mcg/mL Geometric Coefficient of Variation 39	19173 hr*mcg/mL Geometric Coefficient of Variation 23	21053 hr*mcg/mL Geometric Coefficient of Variation 47	27196 hr*mcg/mL Geometric Coefficient of Variation 59

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after single dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single Dose	3.49 days Geometric Coefficient of Variation 28	3.25 days Geometric Coefficient of Variation 44	4.04 days Geometric Coefficient of Variation 23	4.38 days Geometric Coefficient of Variation 39	3.88 days Geometric Coefficient of Variation 38

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after multiple dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Multiple Dose	2.92 days Geometric Coefficient of Variation 13	3.43 days Geometric Coefficient of Variation 43	4.62 days Geometric Coefficient of Variation 17	4.59 days Geometric Coefficient of Variation 36	4.23 days Geometric Coefficient of Variation 37

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1

Time to reach maximum observed plasma concentration of avelumab, after single dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single Dose	1.13 hours Interval 1.0 to 1.22	21.60 hours Interval 5.78 to 25.1	1.99 hours Interval 1.23 to 24.3	1.59 hours Interval 1.17 to 2.0	1.50 hours Interval 1.17 to 6.08

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

Time to reach maximum observed plasma concentration of avelumab, after multiple dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Multiple Dose	1.18 hours Interval 1.02 to 2.0	1.48 hours Interval 0.97 to 7.0	1.32 hours Interval 1.17 to 2.0	1.53 hours Interval 0.98 to 2.0	6.71 hours Interval 6.67 to 6.75

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Pre-Dose Concentration During Multiple Dosing (Ctrough) of Avelumab After Multiple Dose	1.71 mcg/mL Geometric Coefficient of Variation 163	4.03 mcg/mL Geometric Coefficient of Variation 110	2.54 mcg/mL Geometric Coefficient of Variation 125	12.1 mcg/mL Geometric Coefficient of Variation 93	14.4 mcg/mL Geometric Coefficient of Variation 170

PRIMARY outcome

Timeframe: pre-dose, 1, 6, 24, 144, 312 and 527 hours post-dose on Day 1 of Cycle 1

Population: The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab.

The last time point of the last quantifiable concentration (Tlast) of avelumab, after single dose.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Single Dose	168.00 hours Interval 26.5 to 336.0	335.00 hours Interval 165.0 to 336.0	504.50 hours Interval 312.0 to 527.0	334.50 hours Interval 333.0 to 357.0	335.50 hours Interval 290.0 to 360.0

SECONDARY outcome

Timeframe: Day 1 up to Month 14

Population: The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one nAb sample collected for avelumab.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Expansion Phase: Number of Participants With Neutralizing Antibodies (nAb) Status nAb never-positive	3 Participants	—	—	—	—
Expansion Phase: Number of Participants With Neutralizing Antibodies (nAb) Status nAb ever-positive	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 29

Population: Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results. Here "0" in overall number of participants analyzed signifies that there were no ADA ever-positive participants in that specified group".

Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=1 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=3 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 43740	—	0 Participants	1 Participants	1 Participants	—
Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 131220	—	1 Participants	0 Participants	0 Participants	—
Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 180	—	0 Participants	1 Participants	1 Participants	—
Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 4860	—	0 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 up to Month 14

Population: Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results.

Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=1 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 180	1 Participants	—	—	—	—
Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 4860	0 Participants	—	—	—	—
Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 43740	0 Participants	—	—	—	—
Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab 131220	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 up to Month 29

Population: Analysis was performed on participants who had received at least one dose of study drug and who had nAb ever-positive results. Here "0" in overall number of participants analyzed signifies that there were no nAb ever-positive participants in that specified group.

Serum samples were assayed for nAb using a validated analytical method. Number of nAb ever positive participants for serum nAb titer (1) is reported.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=1 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Number of nAb Ever Positive Participants For Serum nAb Titer for Avelumab	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization until disease progression or death due to any cause (maximum duration of 32 months)

Population: The FAS included all randomized participants.

Objective response: complete response (CR) or partial response (PR) according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression (Disease progression: \>= 20% and \>= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease) or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if \>1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in sum of products of greatest diameters. PR was defined \>= 50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by \>=50% in the SPD.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=7 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percentage of Participants With Objective Response as Assessed by Investigator	33.3 percentage of participants Interval 4.3 to 77.7	0 percentage of participants Interval 0.0 to 41.0	83.3 percentage of participants Interval 35.9 to 99.6	33.3 percentage of participants Interval 4.3 to 77.7	66.7 percentage of participants Interval 22.3 to 95.7

SECONDARY outcome

Timeframe: From randomization to PD, death or start of new anti-cancer therapy (maximum duration of 32 months)

Population: FAS included all randomized participants.

DC: best overall response of CR, PR, or stable disease (SD). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if \>1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75% in sum of the products of greatest diameters. PR was defined \>=50% decreased in SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by \>=50% in SPD and SD was defined as \< PR but not progressive disease. To qualify as a best overall response of SD, at least one SD assessment must be observed \>=6 weeks after start date and before disease progression. (Disease progression: \>= 20% and \>= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease).

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=7 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Percentage of Participants With Disease Control (DC) as Assessed by Investigator	50.0 percentage of participants Interval 11.8 to 88.2	57.1 percentage of participants Interval 18.4 to 90.1	100.0 percentage of participants Interval 54.1 to 100.0	66.7 percentage of participants Interval 22.3 to 95.7	66.7 percentage of participants Interval 22.3 to 95.7

SECONDARY outcome

Timeframe: From the date of randomization to the first documentation of objective response (CR or PR) (maximum duration of 32 months)

Population: The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if \>1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined \>=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by \>=50% in the SPD.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Time to Tumor Response (TTR) as Assessed by Investigator	2.6 months Interval 1.7 to 3.5	—	1.5 months Interval 1.4 to 1.6	1.5 months Interval 1.4 to 1.5	2.1 months Interval 1.4 to 2.8

SECONDARY outcome

Timeframe: From first documentation of objective response to date of first documentation of objective PD or death due to any cause (maximum duration of 32 months)

Population: The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

DR is defined, for participants with an objective response, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause, whichever occurs first. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if \>1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined \>=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by \>=50% in the SPD.(PD: \>= 20% and \>= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease).

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=5 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=2 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=4 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Duration of Response (DR) as Assessed by Investigator	NA months Median, upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.	—	6.9 months Interval 4.3 to Upper limits of 95% CI was not estimable due to smaller number of participants with the event.	6.9 months Interval 1.4 to 12.4	9.4 months Interval 1.8 to 9.4

SECONDARY outcome

Timeframe: From randomization to the date of progression of disease or death due to any cause, whichever occurs first (maximum duration of 32 months)

Population: The FAS included all randomized participants.

PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered as progression of disease.

Outcome measures

Outcome measures
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=7 Participants Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 Participants Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.
Lead-in Phase: Progression-Free Survival (PFS) as Assessed by Investigator	NA months Interval 1.7 to Median and upper limits of 95% CI was not estimable due to smaller number of participants with the event.	5.7 months Interval 2.8 to Upper limit of 95% CI was not estimable due to smaller number of participants with the event.	8.5 months Interval 8.5 to Upper limit of 95% CI was not estimable due to smaller number of participants with the event.	3.1 months Interval 1.4 to 5.5	6.1 months Interval 1.4 to 10.8

Timeframe: pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3

Population: Data for this outcome measure was not collected due to early termination of study.

The last time point of the last quantifiable concentration (tlast), after single and multiple dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-treatment tumor biopsy for baseline and on-treatment biopsy at Day 7 of Cycle 3

Population: Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.

Outcome measures

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.	Expansion Phase: Avelumab 70 mg, 500 mg Q2W n=3 participants at risk All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
Infections and infestations Lung infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Encephalitis	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Injury, poisoning and procedural complications Post procedural haemorrhage	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Immune system disorders Graft versus host disease in liver	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Pyrexia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Body temperature increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations C-reactive protein increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Dysarthria	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Hemiparesis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Vascular disorders Orthostatic hypotension	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Condition aggravated	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Disease progression	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.

Other adverse events

Other adverse events
Measure	Lead-in Phase: Avelumab 70 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks.	Lead-in Phase: Avelumab 350 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks.	Lead-in Phase: Avelumab 500 mg Q3W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks.	Lead-in Phase: Avelumab 500 mg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks.	Lead-in Phase: Avelumab 10 mg/kg Q2W n=6 participants at risk Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks.	Expansion Phase: Avelumab 70 mg, 500 mg Q2W n=3 participants at risk All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Cardiac disorders Tachycardia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Endocrine disorders Adrenal insufficiency	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Endocrine disorders Hypopituitarism	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Eye disorders Iritis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Eye disorders Vision blurred	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Abdominal distension	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Constipation	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Gingival pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Lip exfoliation	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Lip swelling	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Nausea	50.0% 3/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Oral pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Asthenia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Chest pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Chills	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Discomfort	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Early satiety	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Fatigue	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Influenza like illness	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Non-cardiac chest pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Oedema peripheral	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Peripheral swelling	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
General disorders Pyrexia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	66.7% 2/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Hepatobiliary disorders Jaundice	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Biliary sepsis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Cellulitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Conjunctivitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Cystitis	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Folliculitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Herpes simplex	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Influenza	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Oral herpes	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Respiratory syncytial virus bronchitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Rhinitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Sinusitis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Urinary tract infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Infections and infestations Vascular device infection	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Alanine aminotransferase	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Alanine aminotransferase increased	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Amylase increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Aspartate aminotransferase	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood alkaline phosphatase	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood triglycerides increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood viscosity increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Electrocardiogram QT prolonged	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Haemoglobin decreased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Lipase increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Transaminases increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Weight decreased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Weight increased	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations White blood cell count decreased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	50.0% 3/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Headache	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Hyperaesthesia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Neuropathy peripheral	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Nervous system disorders Paraesthesia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Psychiatric disorders Agitation	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Psychiatric disorders Anxiety	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Psychiatric disorders Depressed mood	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Psychiatric disorders Insomnia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Renal and urinary disorders Proteinuria	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Reproductive system and breast disorders Breast swelling	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	66.7% 2/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Miliaria	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 1/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	33.3% 2/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Rash papular	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Vascular disorders Orthostatic hypotension	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Vascular disorders Thrombosis	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Blood albumin decreased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Investigations Gamma-glutamyltransferase increased	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	16.7% 1/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/6 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.	0.00% 0/3 • Lead-in phase: From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months), Expansion phase: From first dose of study drug in expansion phase to 90 days after last administration of study drug (maximum duration of 14 months). Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non serious in another participant or 1 participant may have experienced both serious and non serious event during study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER