Trial Outcomes & Findings for Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC (NCT NCT02795429)

NCT ID: NCT02795429

Last Updated: 2023-07-03

Results Overview

Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 89 participants
• Primary outcome timeframe: From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.3 years
• Results posted on: 2023-07-03

Participant Flow

Participants took part in 18 investigative sites in 8 countries.

The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 21 days prior to the first dose of study medication. After screening, the treatment period started on Cycle 1 Day 1.

Participant milestones

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Overall Study STARTED	6	10	11	32	30
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	6	10	11	32	30

Reasons for withdrawal

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Overall Study Adverse Event	1	2	1	2	1
Overall Study Death	1	0	1	2	1
Overall Study Physician Decision	0	0	2	1	5
Overall Study Progressive disease	3	7	6	26	20
Overall Study Subject/guardian decision	1	1	1	1	3

Baseline Characteristics

Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

Baseline characteristics by cohort

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Total n=89 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 7.42 • n=93 Participants	63.2 years STANDARD_DEVIATION 10.24 • n=4 Participants	64.6 years STANDARD_DEVIATION 8.99 • n=27 Participants	64.8 years STANDARD_DEVIATION 10.02 • n=483 Participants	63.4 years STANDARD_DEVIATION 9.97 • n=36 Participants	64.4 years STANDARD_DEVIATION 9.64 • n=10 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	5 Participants n=36 Participants	12 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	8 Participants n=4 Participants	9 Participants n=27 Participants	29 Participants n=483 Participants	25 Participants n=36 Participants	77 Participants n=10 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	12 Participants n=483 Participants	12 Participants n=36 Participants	34 Participants n=10 Participants
Race/Ethnicity, Customized White	3 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	10 Participants n=483 Participants	10 Participants n=36 Participants	36 Participants n=10 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	10 Participants n=483 Participants	8 Participants n=36 Participants	19 Participants n=10 Participants

PRIMARY outcome

Timeframe: From first dose of study medication up to 30 days after last dose, with a maximum duration of 3.3 years

Population: All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part

Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.

AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.

The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs with grade ≥ 3	6 Participants	7 Participants	7 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs with grade ≥ 3	4 Participants	4 Participants	6 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs	6 Participants	10 Participants	10 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs	5 Participants	7 Participants	10 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period SAEs	1 Participants	1 Participants	6 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related SAEs	0 Participants	0 Participants	5 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Fatal SAEs	1 Participants	0 Participants	1 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related fatal SAEs	0 Participants	0 Participants	1 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs leading to discontinuation	3 Participants	4 Participants	4 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs leading to discontinuation	2 Participants	1 Participants	4 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs leading to dose adjustment/interruption	3 Participants	6 Participants	7 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs requiring additional therapy	6 Participants	9 Participants	10 Participants	—	—
Phase Ib: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AE due to infusion reaction	0 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: 42 days

Population: Patients in Phase Ib who either met the minimum exposure criterion and had sufficient safety evaluations, or had experienced a DLT during Cycles 1 and 2. A patient was considered to have met the minimum exposure criterion if received at least 2 doses of spartalizumab and 28 days of capmatinib during Cycles 1 and 2. Patients who did not experience a DLT during the first 2 cycles were considered to have sufficient safety evaluations if they had been observed for at least 42 days after first dose.

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 2 cycles of treatment with capmatinib in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 21 days.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=8 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=9 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First 2 Cycles of Treatment	0 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 3.2 years

Population: All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part

Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.

No dose modifications (i.e. dose reduction) were allowed for spartalizumab.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Capmatinib dose reduction	2 Participants	4 Participants	8 Participants	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Capmatinib dose interruption	4 Participants	6 Participants	8 Participants	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Spartalizumab dose reduction	0 Participants	0 Participants	0 Participants	—	—
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Spartalizumab dose interruption	4 Participants	4 Participants	7 Participants	—	—

PRIMARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 3.2 years

Population: All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part

Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Dose Intensity of Capmatinib	391.2 mg/day Interval 294.0 to 400.0	580.0 mg/day Interval 390.0 to 600.0	755.6 mg/day Interval 371.0 to 800.0	—	—

PRIMARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 3.2 years

Population: All patients who had received at least one dose of spartalizumab or capmatinib in the Phase Ib part

Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Dose Intensity of Spartalizumab	293.18 mg/3W Interval 235.7 to 300.0	300.00 mg/3W Interval 225.0 to 300.0	300.00 mg/3W Interval 272.7 to 300.0	—	—

PRIMARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 2.2 years

Population: All patients to whom study treatment was assigned by randomization in the Phase II part

Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=30 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Overall Response Rate (ORR) Per RECIST v1.1	9.4 percentage of participants Interval 2.0 to 25.0	10.0 percentage of participants Interval 2.1 to 26.5	—	—	—

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per RECIST v1.1.

For RECIST v1.1, R=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression).

The number of participants in each response category is reported in the table.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1 Progressive Disease (PD)	3 Participants	2 Participants	7 Participants	13 Participants	15 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1 Unknown	0 Participants	1 Participants	0 Participants	4 Participants	3 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1 Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1 Partial Response (PR)	2 Participants	0 Participants	2 Participants	3 Participants	3 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per RECIST v1.1 Stable Disease (SD)	1 Participants	7 Participants	2 Participants	12 Participants	9 Participants

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

BOR is defined as the best response recorded from the start of the study treatment until disease progression/recurrence, based on local investigator assessment per Immune-related Response Criteria (irRC).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters; irPD= At least a 20% increase in the sum of diameters of all measured target lesions including new measurable lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm; irSD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for irPD).

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC Immune-related Complete Response (irCR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC Immune-related Partial Response (irPR)	2 Participants	0 Participants	3 Participants	4 Participants	3 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC Immune-related Stable Disease (irSD)	1 Participants	7 Participants	3 Participants	15 Participants	9 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC Immune-related Progressive Disease (irPD)	3 Participants	2 Participants	5 Participants	10 Participants	14 Participants
Phase Ib and Phase II: Best Overall Response (BOR) Per irRC Unknown	0 Participants	1 Participants	0 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.2 years

Population: All patients who had received at least one dose of spartalizumab or capmatinib capmatinib in the Phase Ib part

Tumor response was based on local investigator assessment as per RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Overall Response Rate (ORR) Per RECIST v1.1	33.3 percentage of participants Interval 4.3 to 77.7	0 percentage of participants Interval 0.0 to 30.8	18.2 percentage of participants Interval 2.3 to 51.8	—	—

SECONDARY outcome

Timeframe: From start of treatment until end of treatment, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

Tumor response was based on local investigator assessment as per irRC. ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).

For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new measurable lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Overall Response Rate (ORR) Per irRC	33.3 percentage of participants Interval 4.3 to 77.7	0 percentage of participants Interval 0.0 to 30.8	27.3 percentage of participants Interval 6.0 to 61.0	12.5 percentage of participants Interval 3.5 to 29.0	10.0 percentage of participants Interval 2.1 to 26.5

SECONDARY outcome

Timeframe: From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All participants in Phase Ib and II for whom best overall response is complete response (CR) or partial response (PR) as per RECIST v1.1 based on local investigator assessment.

DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.

According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=2 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=2 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=3 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=3 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Duration of Response (DOR) Per RECIST v1.1	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	—	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.

SECONDARY outcome

Timeframe: From first documented response to first documented disease progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All participants in Phase Ib and II for whom best overall response is immune-related complete response (irCR) or immune-related partial response (irPR) as per irRC based on local investigator assessment.

DOR only applies to patients for whom best overall response is immune-related complete response (irCR) or immune-related partial response (irPR) based on local investigator assessment of overall lesion response according to irRC. DOR is defined as the time from the date of first documented response (confirmed irCR or confirmed irPR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.

According to the statistical analysis plan (SAP), summary estimates of DOR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=2 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=3 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=4 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=3 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Duration of Response (DOR) Per irRC	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	—	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.

SECONDARY outcome

Timeframe: From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

TTR is defined as the time from the date of start of treatment to the date of first documented response (CR or PR, which must be confirmed subsequently) for patients who achieved a confirmed CR or PR. Tumor response was based on local investigator assessment per RECIST v1.1.

Patients who did not achieve a confirmed CR or PR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.

According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed CR or PR in each treatment group/arm.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Time to Response (TTR) Per RECIST v1.1	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.

SECONDARY outcome

Timeframe: From start of treatment until first documented response, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

TTR is defined as the time from the date of start of treatment to the date of first documented response (irCR or irPR, which must be confirmed subsequently) for patients who achieved a confirmed irCR or irPR. Tumor response was based on local investigator assessment per irRC.

Patients who did not achieve a confirmed irCR or irPR were censored at the maximum follow-up time for patients who had a Progression-Free Survival (PFS) event (i.e. either progressed or died due to any cause), or at the date of last adequate tumor assessment before the start of a new anticancer therapy (if any) otherwise.

According to the statistical analysis plan (SAP), summary estimates of TTR using the Kaplan-Meier method were planned to be reported if there were at least 10 patients achieving a confirmed irCR or irPR in each treatment group/arm.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Time to Response (TTR) Per irRC	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.	NA months The estimate could not be provided due to the insufficient number of responders as per SAP.

SECONDARY outcome

Timeframe: From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patientss to whom study treatment was assigned by randomization in the Phase II part.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.

PFS was estimated using the Kaplan-Meier Method.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Progression-Free Survival (PFS) Per RECIST v1.1	3.42 months Interval 1.18 to Not estimable due to insufficient number of participants with events.	4.44 months Interval 1.25 to Not estimable due to insufficient number of participants with events.	1.35 months Interval 1.22 to 13.73	2.79 months Interval 2.6 to 3.88	2.79 months Interval 1.45 to 4.07

SECONDARY outcome

Timeframe: From start of treatment until first documented progression or death due to any cause, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

PFS is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to any cause. If a patient did not experience an event or started a new anticancer therapy, PFS was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.

PFS was estimated using the Kaplan-Meier Method.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Progression-Free Survival (PFS) Per irRC	3.42 months Interval 1.18 to Not estimable due to insufficient number of participants with events.	4.44 months Interval 1.68 to Not estimable due to insufficient number of participants with events.	5.55 months Interval 1.25 to Not estimable due to insufficient number of participants with events.	3.06 months Interval 2.63 to 4.17	2.79 months Interval 1.61 to 5.75

SECONDARY outcome

Timeframe: From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

TTP is defined as the time from the date of start of treatment to the date of the first documented progression per RECIST v1.1 or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per RECIST v1.1.

TTP was estimated using the Kaplan-Meier Method.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Time to Progression (TTP) Per RECIST v1.1	3.42 months Interval 1.18 to Not estimable due to insufficient number of participants with events.	4.44 months Interval 1.25 to Not estimable due to insufficient number of participants with events.	1.35 months Interval 1.22 to Not estimable due to insufficient number of participants with events.	2.79 months Interval 2.6 to 3.88	2.79 months Interval 1.45 to 4.07

SECONDARY outcome

Timeframe: From start of treatment until first documented progression or death due to underlying cancer, assessed up to 3.2 years in Phase Ib and up to 2.2 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

TTP is defined as the time from the date of start of treatment to the date of the first documented and confirmed progression per irRC or death due to underlying cancer. If a patient did not experience an event or started a new anticancer therapy, TTP was censored at the date of the last adequate tumor evaluation before the start of a new anticancer therapy, if any. Tumor response was based on local investigator assessment per irRC.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Time to Progression (TTP) Per irRC	3.42 months Interval 1.18 to Not estimable due to insufficient number of participants with events.	4.44 months Interval 1.68 to Not estimable due to insufficient number of participants with events.	5.55 months Interval 1.25 to Not estimable due to insufficient number of participants with events.	3.06 months Interval 2.63 to 4.17	2.79 months Interval 1.61 to 5.75

SECONDARY outcome

Timeframe: From start of treatment until death due to any cause, assessed up to 3.6 years in Phase Ib and up to 2.9 years in Phase II

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, OS time was censored at the date of last contact.

OS was estimated using the Kaplan-Meier Method.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Overall Survival (OS)	14.98 months Interval 2.37 to Not estimable due to insufficient number of participants with events.	12.11 months Interval 1.68 to 19.45	16.53 months Interval 2.83 to Not estimable due to insufficient number of participants with events.	14.88 months Interval 9.0 to 19.48	9.78 months Interval 3.65 to 22.31

SECONDARY outcome

Timeframe: From first dose of study medication up to 30 days after last dose, with a maximum duration of 2.3 years

Population: All patients to whom study treatment was assigned by randomization in the Phase II part

Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.

AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.

The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=30 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs with grade ≥ 3	25 Participants	15 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs with grade ≥ 3	18 Participants	3 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period SAEs	14 Participants	10 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related SAEs	7 Participants	1 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Fatal SAEs	1 Participants	1 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs leading to discontinuation	10 Participants	1 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs leading to discontinuation	7 Participants	0 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs leading to dose adjustment/interruption	22 Participants	11 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs requiring additional therapy	30 Participants	29 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AE due to infusion reaction	1 Participants	0 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period AEs	32 Participants	30 Participants	—	—	—
Phase II: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period Treatment-related AEs	30 Participants	18 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 2.2 years

Population: All patients to whom study treatment was assigned by randomization in the Phase II part

Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab.

No dose modifications (i.e. dose reduction) were allowed for spartalizumab.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=30 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Capmatinib dose reduction	18 Participants	—	—	—	—
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Capmatinib dose interruption	22 Participants	—	—	—	—
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Spartalizumab dose reduction	0 Participants	0 Participants	—	—	—
Phase II: Number of Participants With Dose Reductions and Dose Interruptions of Capmatinib and Spartalizumab Spartalizumab dose interruption	12 Participants	13 Participants	—	—	—

SECONDARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 2.2 years

Population: All patients assigned by randomization to capmatinib in combination with spartalizumab in the Phase II part

Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Dose Intensity of Capmatinib	696.4 mg/day Interval 167.0 to 800.0	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study medication up to last dose, with a maximum duration of 2.2 years

Population: All patients to whom study treatment was assigned by randomization in the Phase II part

Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=30 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Dose Intensity of Spartalizumab	300.00 mg/3W Interval 200.0 to 300.0	300.00 mg/3W Interval 166.7 to 300.0	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.

Population: All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=4 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=5 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=7 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Maximum Observed Plasma Concentration (Cmax) of Capmatinib	1680 ng/mL Geometric Coefficient of Variation 64.0	3110 ng/mL Geometric Coefficient of Variation 61.2	4980 ng/mL Geometric Coefficient of Variation 23.0	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.

Population: All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=4 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=5 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=7 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib	0.959 hours Interval 0.567 to 1.0	1.00 hours Interval 1.0 to 2.05	1.00 hours Interval 1.0 to 4.22	—	—

SECONDARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 4 and 8 hours post capmatinib dose on Cycle 2 Day 1 (C2D1). The duration of one cycle was 21 days.

Population: All patients in Phase Ib who provided an evaluable capmatinib PK profile on C2D1. Capmatinib PK profile was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after dosing and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=4 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=5 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=7 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib	5740 hours*ng/mL Geometric Coefficient of Variation 51.6	8570 hours*ng/mL Geometric Coefficient of Variation 60.7	16000 hours*ng/mL Geometric Coefficient of Variation 30.6	—	—

SECONDARY outcome

Timeframe: Pre-dose of capmatinib on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1. The duration of one cycle was 21 days.

Population: All patients in Phase II part who provided an evaluable capmatinib concentration at the specified timepoints. Capmatinib concentration was considered evaluable if all the following conditions were satisfied: patient took the same dose of capmatinib for at least 3 consecutive days prior to sampling, patient had the pre-dose sample collected before next dose administration and at least 9 hours after last dose administration, patient did not vomit within 4 hours after the dosing prior to sampling.

Capmatinib plasma concentration was assessed in samples taken at pre-dose. Pre-dose samples were collected before the next dose administration.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase II: Pre-dose Plasma Concentration of Capmatinib Cycle 2 Day 1	607 ng/mL Geometric Coefficient of Variation 99.4	—	—	—	—
Phase II: Pre-dose Plasma Concentration of Capmatinib Cycle 3 Day 1	345 ng/mL Geometric Coefficient of Variation 110	—	—	—	—
Phase II: Pre-dose Plasma Concentration of Capmatinib Cycle 4 Day 1	410 ng/mL Geometric Coefficient of Variation 132	—	—	—	—
Phase II: Pre-dose Plasma Concentration of Capmatinib Cycle 5 Day 1	363 ng/mL Geometric Coefficient of Variation 68.6	—	—	—	—
Phase II: Pre-dose Plasma Concentration of Capmatinib Cycle 6 Day 1	275 ng/mL Geometric Coefficient of Variation 102	—	—	—	—

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.

Population: All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 and Cycle 3. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 1	75.7 µg/mL Geometric Coefficient of Variation 22.6	77.2 µg/mL Geometric Coefficient of Variation 20.9	84.7 µg/mL Geometric Coefficient of Variation 23.3	81.7 µg/mL Geometric Coefficient of Variation 30.1	72.8 µg/mL Geometric Coefficient of Variation 30.9
Phase Ib and Phase II: Maximum Observed Serum Concentration (Cmax) of Spartalizumab Cycle 3	105 µg/mL Geometric Coefficient of Variation 35.8	101 µg/mL Geometric Coefficient of Variation 22.3	128 µg/mL Geometric Coefficient of Variation 20.9	115 µg/mL Geometric Coefficient of Variation 30.2	101 µg/mL Geometric Coefficient of Variation 42.2

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.

Population: All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 Day 1 and Cycle 3 Day 1. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab Cycle 1	1.51 hours Interval 1.42 to 1.77	1.50 hours Interval 0.583 to 1.67	1.50 hours Interval 1.18 to 1.73	1.64 hours Interval 0.917 to 581.0	1.59 hours Interval 0.633 to 22.9
Phase Ib and Phase II: Time to Reach Maximum Serum Concentration (Tmax) of Spartalizumab Cycle 3	1.53 hours Interval 1.5 to 1.6	1.47 hours Interval 1.42 to 22.6	1.52 hours Interval 1.45 to 1.92	1.75 hours Interval 0.0 to 24.2	1.58 hours Interval 1.33 to 22.3

SECONDARY outcome

Timeframe: pre-dose, 1, 24, 48, 72, 168, 240, 336 and 504 hours after completion of spartalizumab infusion on Cycle 1 and Cycle 3. The duration of one cycle was 21 days.

Population: All patients in Phase Ib and Phase II who provided an evaluable PK profile of spartalizumab on Cycle 1 Day 1 and Cycle 3 Day 1. The spartalizumab PK profile was considered evaluable if all the following conditions were satisfied: patient received the planned treatment with spartalizumab and patient provided at least 1 primary PK parameter.

Pharmacokinetic (PK) parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab Cycle 1	739 day*µg/mL Geometric Coefficient of Variation 24.7	726 day*µg/mL Geometric Coefficient of Variation 20.9	813 day*µg/mL Geometric Coefficient of Variation 19.4	805 day*µg/mL Geometric Coefficient of Variation 33.4	693 day*µg/mL Geometric Coefficient of Variation 35.3
Phase Ib and Phase II: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab Cycle 3	1280 day*µg/mL Geometric Coefficient of Variation 39.2	1220 day*µg/mL Geometric Coefficient of Variation 25.5	1630 day*µg/mL Geometric Coefficient of Variation 23.2	1330 day*µg/mL Geometric Coefficient of Variation 41.6	883 day*µg/mL Geometric Coefficient of Variation 79.1

SECONDARY outcome

Timeframe: Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).

Population: All patients who received at least one dose of study treatment in the Phase Ib part and had a valid assessment for the outcome measure, and all patients to whom study treatment was assigned by randomization in the Phase II part and had a valid assessment for the outcome measure.

The expression of CD8 was measured in tumor samples by immunohistochemical methods. This record summarizes the percent marker area for CD8 expression in tumor samples.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=5 Tumor samples Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=15 Tumor samples Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=10 Tumor samples Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=29 Tumor samples Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=31 Tumor samples Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: Percent Marker Area for CD8 Expression in Tumor Samples Baseline	0.6 CD8 percent marker area Interval 0.0 to 1.0	0.9 CD8 percent marker area Interval 0.0 to 37.0	0.4 CD8 percent marker area Interval 0.0 to 3.0	0.5 CD8 percent marker area Interval 0.0 to 5.0	0.3 CD8 percent marker area Interval 0.0 to 27.0
Phase Ib and Phase II: Percent Marker Area for CD8 Expression in Tumor Samples Post-baseline	3.0 CD8 percent marker area Interval 3.0 to 3.0	2.6 CD8 percent marker area Interval 0.0 to 14.0	1.0 CD8 percent marker area Interval 0.0 to 1.0	1.3 CD8 percent marker area Interval 0.0 to 7.0	0.9 CD8 percent marker area Interval 0.0 to 21.0

SECONDARY outcome

Timeframe: Baseline (screening) and post-baseline (assessed throughout the treatment up to maximum 115 days).

Population: All patients who received at least one dose of study treatment in the Phase Ib part and had a valid assessment for the outcome measure, and all patients to whom study treatment was assigned by randomization in the Phase II part and had a valid assessment for the outcome measure.

The expression of programmed cell death-ligand 1 (PD-L1) was measured in tumor samples by immunohistochemical methods. This record summarizes the PD-L1 positivity percentage in tumor samples.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Tumor samples Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=16 Tumor samples Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=10 Tumor samples Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=31 Tumor samples Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=32 Tumor samples Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: PD-L1 Percent Positive Tumor Baseline	0.0 PD-L1 positivity percentage Interval 0.0 to 5.0	0.0 PD-L1 positivity percentage Interval 0.0 to 90.0	0.0 PD-L1 positivity percentage Interval 0.0 to 2.0	0.0 PD-L1 positivity percentage Interval 0.0 to 7.0	0.0 PD-L1 positivity percentage Interval 0.0 to 3.0
Phase Ib and Phase II: PD-L1 Percent Positive Tumor Post-baseline	12.5 PD-L1 positivity percentage Interval 0.0 to 25.0	0.0 PD-L1 positivity percentage Interval 0.0 to 100.0	0.0 PD-L1 positivity percentage Interval 0.0 to 5.0	0.0 PD-L1 positivity percentage Interval 0.0 to 3.0	0.0 PD-L1 positivity percentage Interval 0.0 to 5.0

POST_HOC outcome

Timeframe: On-treatment and post-treatment safety follow-up deaths: up to 3.6 years in Phase Ib and 2.6 years in Phase II. Post treatment survival follow-up deaths: up to 3.6 years in Phase Ib and 2.9 years in Phase II.

Population: All patients who received at least one dose of study treatment in the Phase Ib part, and all patients to whom study treatment was assigned by randomization in the Phase II part.

On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 150 days after the last dose of study medication.

Post-treatment survival follow-up deaths were collected from day 151 after last dose of study medication to end of study.

All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus post-treatment survival follow-up deaths.

Outcome measures

Measure	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W n=6 Participants Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W n=10 Participants Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=11 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W n=32 Participants Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II	Phase II: Spartalizumab 300 mg Q3W n=30 Participants Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II
Phase Ib and Phase II: All-Collected Deaths Post-treatment survival follow-up deaths	3 participants	5 participants	4 participants	15 participants	10 participants
Phase Ib and Phase II: All-Collected Deaths All deaths	6 participants	8 participants	8 participants	23 participants	23 participants
Phase Ib and Phase II: All-Collected Deaths On-treatment and post-treatment safety follow-up deaths	3 participants	3 participants	4 participants	8 participants	13 participants

Adverse Events

Phase Ib: Capmatinib 200mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU

Serious events: 1 serious events

Other events: 6 other events

Deaths: 3 deaths

Phase Ib: Capmatinib 300mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU

Serious events: 1 serious events

Other events: 10 other events

Deaths: 3 deaths

Phase Ib: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU

Serious events: 6 serious events

Other events: 10 other events

Deaths: 4 deaths

Phase II: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU

Serious events: 14 serious events

Other events: 32 other events

Deaths: 8 deaths

Phase II: Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU

Serious events: 12 serious events

Other events: 30 other events

Deaths: 13 deaths

Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Phase II: Spartalizumab 300 mg Q3W - Post-treatment Survival FU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Measure	Phase Ib: Capmatinib 200mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=6 participants at risk AEs during on-treatment period and post-treatment safety follow-up (FU) (up to 150 days post-treatment)	Phase Ib: Capmatinib 300mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=10 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase Ib: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=11 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase II: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=32 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase II: Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=30 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase II: Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Cardiac disorders Cardiac arrest	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Eye disorders Vision blurred	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Ascites	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Melaena	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Oedema peripheral	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Pyrexia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Biliary obstruction	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Hepatorenal syndrome	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Immune system disorders Hypersensitivity	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Bacteraemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Cellulitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Influenza	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Sepsis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Blood bilirubin increased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Blood corticotrophin decreased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Liver function test abnormal	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Encephalopathy	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Hepatic encephalopathy	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Chronic kidney disease	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Haematuria	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.

Other adverse events

Measure	Phase Ib: Capmatinib 200mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=6 participants at risk AEs during on-treatment period and post-treatment safety follow-up (FU) (up to 150 days post-treatment)	Phase Ib: Capmatinib 300mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=10 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase Ib: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=11 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase II: Capmatinib 400mg BID + Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=32 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase II: Spartalizumab 300mg Q3W - On-treatment and Post-treatment Safety FU n=30 participants at risk AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)	Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period	Phase II: Spartalizumab 300 mg Q3W - Post-treatment Survival FU Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Cardiac disorders Angina pectoris	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Cardiac disorders Angina unstable	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Cardiac disorders Atrioventricular block first degree	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Endocrine disorders Adrenal insufficiency	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Eye disorders Cataract	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Eye disorders Diplopia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Eye disorders Dry eye	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	21.9% 7/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Anal fissure	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Aptyalism	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Ascites	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	21.9% 7/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Chapped lips	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Constipation	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	30.0% 3/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	31.2% 10/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Nausea	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	45.5% 5/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	46.9% 15/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Plicated tongue	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	40.0% 4/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Toothache	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	28.1% 9/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Asthenia	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	43.8% 14/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Chills	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Fatigue	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	30.0% 3/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	36.4% 4/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Influenza like illness	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Malaise	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Nodule	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Non-cardiac chest pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Oedema	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Oedema peripheral	66.7% 4/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	60.0% 6/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	54.5% 6/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	46.9% 15/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
General disorders Pyrexia	50.0% 3/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	36.4% 4/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	43.8% 14/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	16.7% 5/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Hepatobiliary disorders Liver injury	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Immune system disorders Anaphylactic reaction	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Abscess neck	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Bronchitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Cellulitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Folliculitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Oral candidiasis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Oral fungal infection	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Paronychia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Pneumonia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Alanine aminotransferase increased	50.0% 3/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	45.5% 5/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 6/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Amylase increased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	21.9% 7/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	33.3% 10/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Bilirubin conjugated increased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Blood alkaline phosphatase increased	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Blood bilirubin increased	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	25.0% 8/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Blood creatinine increased	50.0% 3/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Creatinine renal clearance decreased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Electrocardiogram QT prolonged	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Lipase increased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.8% 6/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Lymphocyte count decreased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Neutrophil count decreased	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Platelet count decreased	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Weight decreased	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Investigations Weight increased	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	46.9% 15/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	30.0% 3/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	28.1% 9/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	30.0% 3/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Joint swelling	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Cerebral ischaemia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Dizziness	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Dysaesthesia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Dysgeusia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	18.2% 2/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Headache	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 3/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Neuralgia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Paraesthesia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Nervous system disorders Serotonin syndrome	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Psychiatric disorders Depression	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Psychiatric disorders Insomnia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Psychiatric disorders Irritability	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Dysuria	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	15.6% 5/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Blister	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Decubitus ulcer	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Dry skin	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Lichenoid keratosis	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Pruritus	50.0% 3/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	20.0% 2/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	36.4% 4/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	26.7% 8/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.7% 2/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	30.0% 3/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	27.3% 3/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	12.5% 4/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	13.3% 4/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.4% 3/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.3% 1/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	10.0% 1/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Vascular disorders Haematoma	16.7% 1/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Vascular disorders Hot flush	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	6.2% 2/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.
Vascular disorders Hypotension	33.3% 2/6 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/10 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	9.1% 1/11 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	3.1% 1/32 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.	— 0/0 • Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up), up to 3.6 years in Phase Ib and 2.6 years in Phase II. Deaths were collected in the post treatment survival follow up from 151 days after last dose of study medication until the end of the study, up to 3.6 years in Phase Ib and 2.9 years in Phase II. These are not considered AEs Any sign or symptom that occurs during the on-treatment and safety follow-up periods. Deaths in the post treatment survival follow-up are not considered Adverse Events.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER