Trial Outcomes & Findings for BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC) (NCT NCT02204072)

NCT ID: NCT02204072

Last Updated: 2025-07-15

Results Overview

Number of patients with DLTs were used to determine the maximum tolerated dose (MTD) in the Phase Ib escalation part. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 120 participants
• Primary outcome timeframe: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.
• Results posted on: 2025-07-15

Participant Flow

A multicentre, open-label, randomised study to determine the safety, tolerability and anti-tumour activity of xentuzumab (BI 836845) in combination with enzalutamide in patients with advanced prostate cancer that has spread. The trial consists of 3 parts: Phase 1b dose escalation part, Phase 1b expansion part, Phase 2 two arm, parallel design.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated

Participant milestones

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib expansion part.	Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase II part.	Phase II: 160 mg Enzalutamide Four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Phase II part.
Overall Study STARTED	3	7	24	43	43
Overall Study Treated	3	7	24	43	43
Overall Study Discontinued Xentuzumab Due to Progressive Disease	2	4	21	24	0
Overall Study Discontinued Xentuzumab Due to Adverse Event	0	3	0	7	0
Overall Study Discontinued Xentuzumab Due to Withdrawal by Subject	1	0	2	9	0
Overall Study Discontinued Xentuzumab Due to Other Reason	0	0	1	1	0
Overall Study COMPLETED	0	0	0	2	0
Overall Study NOT COMPLETED	3	7	24	41	43

Reasons for withdrawal

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib expansion part.	Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase II part.	Phase II: 160 mg Enzalutamide Four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Phase II part.
Overall Study Discontinued Enzalutamide due to withdrawal by subject	1	0	2	9	6
Overall Study Discontinued Enzalutamide due to adverse events	0	3	1	6	6
Overall Study Discontinued Enzalutamide due to progressive disease	2	4	19	26	31
Overall Study Discontinued Enzalutamide due to other reason	0	0	2	0	0

Baseline Characteristics

Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.

Baseline characteristics by cohort

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=3 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=7 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide n=24 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib expansion part.	Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase II part.	Phase II: 160 mg Enzalutamide n=43 Participants Four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Phase II part.	Total n=120 Participants Total of all reporting groups
Age, Continuous	68.67 Years STANDARD_DEVIATION 11.85 • n=3 Participants	70.71 Years STANDARD_DEVIATION 7.09 • n=7 Participants	73.38 Years STANDARD_DEVIATION 7.81 • n=24 Participants	68.58 Years STANDARD_DEVIATION 8.80 • n=43 Participants	69.91 Years STANDARD_DEVIATION 7.92 • n=43 Participants	70.14 Years STANDARD_DEVIATION 8.32 • n=120 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	0 Participants n=43 Participants	0 Participants n=43 Participants	0 Participants n=120 Participants
Sex: Female, Male Male	3 Participants n=3 Participants	7 Participants n=7 Participants	24 Participants n=24 Participants	43 Participants n=43 Participants	43 Participants n=43 Participants	120 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants	0 Participants n=7 Participants	4 Participants n=24 Participants	5 Participants n=43 Participants	12 Participants n=43 Participants	21 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants	7 Participants n=7 Participants	20 Participants n=24 Participants	37 Participants n=43 Participants	31 Participants n=43 Participants	98 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	1 Participants n=43 Participants	0 Participants n=43 Participants	1 Participants n=120 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	0 Participants n=43 Participants	0 Participants n=43 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	15 Participants n=43 Participants	10 Participants n=43 Participants	25 Participants n=120 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	0 Participants n=43 Participants	0 Participants n=43 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=24 Participants	0 Participants n=43 Participants	0 Participants n=43 Participants	1 Participants n=120 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants	7 Participants n=7 Participants	23 Participants n=24 Participants	27 Participants n=43 Participants	33 Participants n=43 Participants	93 Participants n=120 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	0 Participants n=43 Participants	0 Participants n=43 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=24 Participants	1 Participants n=43 Participants	0 Participants n=43 Participants	1 Participants n=120 Participants
Prostate Surface Antigen (PSA) at baseline	272.03 Micorgram / Liter STANDARD_DEVIATION 100.38 • n=3 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.	437.99 Micorgram / Liter STANDARD_DEVIATION 390.02 • n=7 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.	113.59 Micorgram / Liter STANDARD_DEVIATION 252.65 • n=24 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.	671.23 Micorgram / Liter STANDARD_DEVIATION 935.44 • n=43 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.	562.97 Micorgram / Liter STANDARD_DEVIATION 1592.71 • n=42 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.	496.77 Micorgram / Liter STANDARD_DEVIATION 1120.62 • n=119 Participants • Phase 1b escalation part and Phase 1b expansion part: Treated Set. Phase II: Randomised Set.

PRIMARY outcome

Timeframe: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.

Population: MTD-set: The MTD set defined the set of patients in the Phase Ib escalation part who were fully evaluable for determination of the MTD in the first treatment course. 1 patient in the 1000 mg Xentuzumab + 160 mg Enzalutamide arm was not evaluable for the MTD determination due to missed doses. Phase Ib escalation part.

Number of patients with DLTs were used to determine the maximum tolerated dose (MTD) in the Phase Ib escalation part. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=3 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=6 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase Ib Escalation Part: Number of Patients With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first administration of xentuzumab up to start of Cycle 2, up to 28 days.

Population: MTD-set: The MTD set defined the set of patients in the Phase Ib escalation part who were fully evaluable for determination of the MTD in the first treatment course. 1 patient in the 1000 mg Xentuzumab + 160 mg Enzalutamide arm was not evaluable for the MTD determination due to missed doses. Phase Ib escalation part.

Maximum tolerated dose (MTD) based on the occurrence of dose limiting toxicity (DLT) during the first treatment course. The MTD in this study was defined as the highest protocol dose level of xentuzumab in combination with enzalutamide, at which no more than 1 out of 6 patients in a cohort experienced a DLT during the MTD evaluation period.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=9 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase Ib Escalation Part: Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose Limiting Toxicity (DLT) During the First Treatment Course	1000 Milligram	—

PRIMARY outcome

Timeframe: At Cycle 1 Day 1 before study treatment and from Cycle 3 Day 1 and Day 1 of every cycle thereafter until the end of treatment, up to 35 months.

Population: Treated Set (TS): All patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Phase Ib expansion part.

The primary endpoint of the Phase Ib expansion part was PSA response. PSA response was defined as a decline in PSA value >50% compared to baseline which was confirmed by the next available value occurring at least 3 weeks later. The confirmatory value had to be at least 50% lower than the baseline, but could be higher than the first PSA value taken into account for response. However the confirmatory value was not allowed to be 50% higher than this first PSA value. If it was ≥ 50% higher than the first PSA value, the next available sample was to be taken to determine if response had been achieved. The date of response was the date that the first 50% (or greater) decline was observed. Number of participants with response is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=24 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase Ib Expansion Part: Prostate Specific Antigen (PSA) Response Yes, Confirmed	1 Participants	—
Phase Ib Expansion Part: Prostate Specific Antigen (PSA) Response Yes, Unconfirmed	1 Participants	—
Phase Ib Expansion Part: Prostate Specific Antigen (PSA) Response No	21 Participants	—
Phase Ib Expansion Part: Prostate Specific Antigen (PSA) Response Missing	1 Participants	—

PRIMARY outcome

Timeframe: From randomisation until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1269 days.

Population: Randomised Set (RS): All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

PFS was calculated as follows:

For patients with 'event' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

PFS [days] = date of outcome - date of randomisation + 1.

For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

PFS (censored) [days] = date of outcome - date of randomisation + 1.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Progression Free Survival (PFS) Based on Investigator Assessment	7.4 Months Interval 3.5 to 8.7	6.2 Months Interval 3.5 to 11.1

SECONDARY outcome

Timeframe: From first treatment administration of any study medication until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1114 days.

Population: Treated Set (TS): All patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Phase Ib expansion part.

PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

PFS was calculated as follows:

For patients with 'event' as an outcome for PFS: (according to modified RECIST version 1.1 or PCWG2) PFS [days] = date of outcome - date of first treatment administration + 1.

For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

PFS (censored) [days] = date of outcome - date of first treatment administration + 1.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=24 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase Ib Expansion Part: Progression Free Survival (PFS) Based on Investigator Assessment	8.2 Months Interval 3.5 to 14.6	—

SECONDARY outcome

Timeframe: Prior to study drug administration at Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3, Day 1 Cycle 5, Day 1 Cycle 7 and every 12 weeks thereafter, up to end of treatment. Up to 35 months.

Population: Treated Set (TS): All patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). Only participants with baseline CTC value \>= 5 cells per 7.5mL were included in the analysis. Phase Ib expansion part.

Changes in circulating tumour cells (CTC) response - CTC reduction from >=5 to <5 cells per 7.5 mL blood for at least one post-baseline time point. Number of participants with CTC Response (yes/no) is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=9 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase Ib Expansion Part: Changes in Circulating Tumour Cells (CTC) Response - CTC Reduction From >=5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time Point Yes	1 Participants	—
Phase Ib Expansion Part: Changes in Circulating Tumour Cells (CTC) Response - CTC Reduction From >=5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time Point No	8 Participants	—

SECONDARY outcome

Timeframe: From randomisation until radiological tumor progression or death from any cause, whichever occurred earlier, up to 1269 days.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

PFS was defined as the time from randomisation until radiological tumour progression in bone (based on Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria) or soft tissue (based on modified RECIST 1.1) or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. Median PFS time in months is reported.

PFS was calculated as follows:

For patients with 'event' as an outcome for PFS: (according to modified RECIST version 1.1 or PCWG2) PFS [days] = date of outcome - date of first treatment administration + 1.

For patients with 'censored' as an outcome for PFS (according to modified RECIST version 1.1 or PCWG2):

PFS (censored) [days] = date of outcome - date of first treatment administration + 1.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Radiological Progression Free Survival (PFS), Based on Central Review	3.6 Months Interval 3.5 to 8.1	7.1 Months Interval 3.6 to 8.2

SECONDARY outcome

Timeframe: From randomisation until radiological tumor progression or death from any cause (until cut-off date for final analysis), whichever occurred earlier, up to 1269 days.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

Overall survival (OS) defined as the time from randomisation to death from any cause. Median survival time in months is reported.

Overall survival at cut-off date for final analysis (24-Oct-2019) is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Overall Survival (OS)	13.6 Months Interval 8.7 to 19.4	13.6 Months Interval 8.7 to 21.3

SECONDARY outcome

Timeframe: At screening, at Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

For the definition of time to PSA progression, the following rules are used:

• Decline from baseline in PSA before increasing: Time to PSA progression is defined as the time from the date of randomisation until the date where a 25% or greater increase in PSA and an absolute increase of 2 ng/mL or more from baseline, is documented (which is confirmed by the next available value occurring at least 3 weeks later).
• No decline from baseline in PSA: Time to PSA progression is defined as the time from the date of randomisation until the date where a 25% or greater increase in PSA and an absolute increase of 2 ng/mL or more from baseline, is documented. However, only values after 12 weeks of therapy are considered.

Time to PSA progression [days] = date of PSA progression - date of randomisation + 1.

For patients not presenting with PSA progression or being lost to follow-up:

Time to PSA progression (censored) [days] = date of censoring - date of randomisation + 1.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Time to Prostate Specific Antigen (PSA) Progression	4.6 Months Interval 2.8 to 5.7	3.7 Months Interval 2.8 to 4.6

SECONDARY outcome

Timeframe: At screening, at Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

Population: Randomised Set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Only participants with non-missing values were included in the analysis. Phase II part.

Maximum decline in (PSA) compared to baseline. The maximum decline in PSA is defined as the change in PSA between the baseline PSA value and the minimum post-baseline PSA value. The change from baseline is defined as: Change from baseline in PSA (ng/mL) = PSA value post-baseline - PSA value at baseline.

Maximum decline in PSA is defined as:

Maximum decline in PSA (ng/mL) = min(PSA value post-baseline) - PSA value at baseline.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=40 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=37 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Maximum Decline in Prostate Specific Antigen (PSA)	-102.20 Microgram / Liter Standard Deviation 580.59	-94.13 Microgram / Liter Standard Deviation 1020.31

SECONDARY outcome

Timeframe: At baseline and at Week 12.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Only participants with non-missing values were included in the analysis. Phase II part.

Percentage change in PSA from baseline to Week 12. Percentage change in PSA from baseline to week 12 of treatment is defined as:

Percentage change in PSA (%) = 100*(PSA value at week 12 - PSA value at baseline)/PSA value at baseline

For this assessment, it is allowed to take a value:

• until one week later than week 12, in case the PSA assessment was delayed
• one day earlier due to the one day window allowed by the protocol Values from assessments between day 84 and day 92 after first treatment administration will therefore be taken into account (according to the protocol schedule for visits at week 12).

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=31 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=30 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Percentage Change in Prostate Specific Antigen (PSA) at Week 12	10.13 Percentage change Standard Deviation 83.25	49.72 Percentage change Standard Deviation 109.91

SECONDARY outcome

Timeframe: At Cycle 1 Day 1 and from Cycle 3 Day 1 and at Day 1 of every cycle thereafter until end of treatment, up to 40.1 months.

Population: Randomised Set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

PSA response - defined as a decline in PSA value >50% (which is confirmed by a second value 3 to 4 weeks apart).

PSA response was defined as a decline in PSA value >50% compared to baseline which was confirmed by the next available value occurring at least 3 weeks later. The confirmatory value had to be at least 50% lower than the baseline, but could be higher than the first PSA value taken into account for response. However the confirmatory value was not allowed to be 50% higher than this first PSA value. If it was ≥ 50% higher than the first PSA value, the next available sample was to be taken to determine if response had been achieved. Number of participants with response is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Prostate Specific Antigen (PSA) Response No	31 Participants	29 Participants
Phase II Part: Prostate Specific Antigen (PSA) Response Yes - confirmed	7 Participants	8 Participants
Phase II Part: Prostate Specific Antigen (PSA) Response Yes - unconfirmed	2 Participants	0 Participants
Phase II Part: Prostate Specific Antigen (PSA) Response Missing	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Prior to study drug administration at Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1 and then every 12 weeks thereafter, until end of treatment. Up to 40.1 months.

Population: Randomised Set (RS): This patient set included all randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Only patients with baseline CTC value \>=5 cells per 7.5mL were included in the analysis. Phase II part.

CTC reduction is defined as CTC decline from ≥5 to <5 cells per 7.5 mL blood for at least one post-baseline time-point. Patients with a CTC value < 5 cells per 7.5mL blood at baseline, or with missing baseline values were not taken into consideration for this endpoint. Baseline value is the value collected before a patient starts treatment with trial medication.

Number of participants per category is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=25 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=19 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Circulating Tumour Cells (CTC) Reduction Defined as CTC Decline From ≥5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time-point Yes	4 Participants	2 Participants
Phase II Part: Circulating Tumour Cells (CTC) Reduction Defined as CTC Decline From ≥5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time-point No	19 Participants	15 Participants
Phase II Part: Circulating Tumour Cells (CTC) Reduction Defined as CTC Decline From ≥5 to <5 Cells Per 7.5 mL Blood for at Least One Post-baseline Time-point Missing on treatment	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Prior to study drug administration at Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1 and then every 12 weeks thereafter, until end of treatment. Up to 40.1 months.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Only participants with baseline CTC value were included in the analysis. Phase II part.

Maximum decline in CTC counts (in number of cells) compared with baseline that occurred at any point after treatment start , defined as the difference between the minimum post-baseline CTC value and the baseline CTC value. Patients with missing baseline value are considered missing for this criterion. Baseline value is the value collected before a patient starts treatment with trial medication. Positive values for maximum decline in CTC are possible in case no decline in CTC occurred. This indicates an increase in CTC.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=32 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=28 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Maximum Decline (%) in Circulating Tumour Cells (CTC) Counts	41.96 Percentage (%) Standard Deviation 289.085	21.33 Percentage (%) Standard Deviation 201.353

SECONDARY outcome

Timeframe: At Week 12.

Population: Randomised Set: All randomised patients in the Phase II part, regardless of whether or not they received treatment. Patients were assigned to xentuzumab in combination with enzalutamide or enzalutamide alone. Phase II part.

CTC status (≥5 or <5 cells per 7.5mL blood) at Week 12. Number of participants per category is reported.

Outcome measures

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 Participants 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.
Phase II Part: Circulating Tumour Cells (CTC) Status at Week 12 <5 cells per 7.5ml blood	11 Participants	16 Participants
Phase II Part: Circulating Tumour Cells (CTC) Status at Week 12 Missing on treatment	6 Participants	7 Participants
Phase II Part: Circulating Tumour Cells (CTC) Status at Week 12 ≥5 cells per 7.5ml blood	26 Participants	20 Participants

Adverse Events

Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide

Serious events: 5 serious events

Other events: 7 other events

Deaths: 2 deaths

Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide

Serious events: 8 serious events

Other events: 24 other events

Deaths: 0 deaths

Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide

Serious events: 19 serious events

Other events: 43 other events

Deaths: 34 deaths

Phase II: 160 mg Enzalutamide

Serious events: 17 serious events

Other events: 43 other events

Deaths: 31 deaths

Serious adverse events

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=3 participants at risk 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=7 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide n=24 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib expansion part.	Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase II part.	Phase II: 160 mg Enzalutamide n=43 participants at risk Four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Phase II part.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Cardiac disorders Myocardial infarction	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Cardiac disorders Palpitations	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Eye disorders Cataract	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Eye disorders Retinal detachment	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Nausea	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Vomiting	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Asthenia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Chest pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Condition aggravated	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Fatigue	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders General physical health deterioration	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Pyrexia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Infection	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Osteomyelitis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Pulmonary sepsis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Sepsis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Urinary tract infection	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Urosepsis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Viral infection	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Electrocardiogram T wave inversion	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Cauda equina syndrome	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Hypersomnia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Paraesthesia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Spinal cord compression	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Haematuria	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Hydronephrosis	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Urinary retention	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Circulatory collapse	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.

Other adverse events

Measure	Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide n=3 participants at risk 750 milligram (mg) xentuzumab (10mg/milliliter (mL)) was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide n=7 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib escalation part.	Phase Ib Expansion: 1000 mg Xentuzumab + 160 mg Enzalutamide n=24 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase Ib expansion part.	Phase II: 1000 mg Xentuzumab + 160 mg Enzalutamide n=43 participants at risk 1000 milligram (mg) xentuzumab (10mg/mL was supplied in 20mL vials and diluted in physiological sodium chloride solution (0.9%)) as liquid formulation was administered as weekly 1-hour intravenous (i.v.) infusion on Days 1, 8, 15 and 22 together with four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Infusion duration of xentuzumab could be extended to more than 1 hour in case of infusion reaction or adverse events. Phase II part.	Phase II: 160 mg Enzalutamide n=43 participants at risk Four liquid-filled soft gelatin capsules of 40mg (total: 160mg) enzalutamide administered orally once daily during each 28-day cycle of treatment until disease progression or occurrence of undue toxicities. Phase II part.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.7% 4/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	34.9% 15/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	44.2% 19/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Abdominal discomfort	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	42.9% 3/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Constipation	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	71.4% 5/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	20.8% 5/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	25.6% 11/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	32.6% 14/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	23.3% 10/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	23.3% 10/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Nausea	66.7% 2/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	57.1% 4/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	33.3% 8/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	25.6% 11/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	27.9% 12/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Vomiting	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	20.9% 9/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	20.9% 9/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Asthenia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.3% 7/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	25.6% 11/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Fatigue	100.0% 3/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	71.4% 5/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	37.5% 9/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	67.4% 29/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	48.8% 21/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Oedema peripheral	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Peripheral swelling	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Pyrexia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Nasopharyngitis	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Oral candidiasis	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Urinary tract infection	66.7% 2/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.7% 4/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Viral infection	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Electrocardiogram T wave inversion	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Neutrophil count decreased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Platelet count decreased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Weight decreased	66.7% 2/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.7% 4/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	37.2% 16/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations White blood cell count decreased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Decreased appetite	100.0% 3/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	42.9% 3/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	37.5% 9/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	60.5% 26/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	60.5% 26/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.7% 4/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	57.1% 4/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	58.3% 14/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	30.2% 13/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	44.2% 19/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	42.9% 3/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	50.0% 12/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	30.2% 13/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	39.5% 17/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.7% 4/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	12.5% 3/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	25.0% 6/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.3% 7/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	23.3% 10/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Amnesia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Dizziness	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	20.8% 5/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Dysgeusia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Headache	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	25.0% 6/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Lethargy	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Paraesthesia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Somnolence	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Taste disorder	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Psychiatric disorders Depressed mood	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Psychiatric disorders Insomnia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	42.9% 3/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.3% 7/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Psychiatric disorders Nightmare	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Dysuria	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Haematuria	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Pollakiuria	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Urinary retention	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Reproductive system and breast disorders Pelvic pain	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.3% 7/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	11.6% 5/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	18.6% 8/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.0% 6/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Hot flush	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	16.3% 7/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Hypertension	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	7.0% 3/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	9.3% 4/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Vascular disorders Hypotension	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Cardiac disorders Palpitations	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Cardiac disorders Tachycardia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Flatulence	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Chest discomfort	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders General physical health deterioration	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
General disorders Malaise	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Infected skin ulcer	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Infections and infestations Pneumonia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.7% 2/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Blood calcium decreased	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	28.6% 2/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Psychiatric disorders Distractibility	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Renal and urinary disorders Proteinuria	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	8.3% 2/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	2.3% 1/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	14.3% 1/7 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	4.2% 1/24 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.	0.00% 0/43 • [All cause mortality]: Up to 430 days for Phase 1b escalation, up to 1107 days Phase 1b expansion and up to 1322 days for Phase II part. [Serious and other Adverse events]. From first drug administration until last drug administration + residual effect period of 42 days, up to 370 days for Phase 1b escalation, up to 1107 days for Phase 1b expansion, up to 1262 days for Phase II. Treated Set (TS): This patient set included all patients who were documented to have received and taken at least one dose of any study medication during the treatment cycles (from Day 1). All-cause mortality includes all death throughout the whole study period, also including death reports after the cut-off date of the final analysis.

Additional Information

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