Trial Outcomes & Findings for A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma (NCT NCT03301636)

NCT ID: NCT03301636

Last Updated: 2022-09-27

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2022-09-27

Participant Flow

Participant milestones

Measure	Dose Level 1 Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr	Dose Level 2 Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr	Dose Level 3 Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr
Overall Study STARTED	7	6	8
Overall Study COMPLETED	7	6	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

Baseline characteristics by cohort

Measure	Dose Level 1 n=7 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr	Dose Level 2 n=6 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr	Dose Level 3 n=8 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr	Total n=21 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 15.14 • n=5 Participants	61.8 years STANDARD_DEVIATION 14.77 • n=7 Participants	61.9 years STANDARD_DEVIATION 8.22 • n=5 Participants	61.3 years STANDARD_DEVIATION 12.15 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Height	171.3 Centimeters STANDARD_DEVIATION 10.56 • n=5 Participants	168.8 Centimeters STANDARD_DEVIATION 8.86 • n=7 Participants	172.9 Centimeters STANDARD_DEVIATION 10.25 • n=5 Participants	171.1 Centimeters STANDARD_DEVIATION 9.59 • n=4 Participants
Weight	102.77 Kilograms STANDARD_DEVIATION 22.3 • n=5 Participants	75.12 Kilograms STANDARD_DEVIATION 13.009 • n=7 Participants	117.44 Kilograms STANDARD_DEVIATION 26.960 • n=5 Participants	100.46 Kilograms STANDARD_DEVIATION 27.502 • n=4 Participants

PRIMARY outcome

Timeframe: 28 Days

Outcome measures

Measure	Dose Level 1 n=7 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr	Dose Level 2 n=6 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr	Dose Level 3 n=8 Participants Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr
Number of Participants With Regimen-limiting Toxicities (RLTs) of Indoximod in Combination With Pembrolizumab	1 Participants	1 Participants	0 Participants

Adverse Events

Dose Level 1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 2 deaths

Dose Level 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Level 3

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Measure	Dose Level 1 n=7 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr	Dose Level 2 n=6 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr	Dose Level 3 n=7 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr
Nervous system disorders Haemorrhage intracranial	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Headache	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Investigations Alanine aminotransferase increased	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.

Other adverse events

Measure	Dose Level 1 n=7 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 600mg Q12 hr	Dose Level 2 n=6 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 1200mg Q12 hr	Dose Level 3 n=7 participants at risk Pembrolizumab 200mg Q3 weeks and Indoximod 1800mg Q12 hr
Skin and subcutaneous tissue disorders Rash	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Pruritus	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	50.0% 3/6 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Onychomadesis	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Psoriasis	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Skin hypopigmentation	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Skin and subcutaneous tissue disorders Skin lesion	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Fatigue	57.1% 4/7 • Number of events 4 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	57.1% 4/7 • Number of events 4 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Pyrexia	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Chills	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Mucosal inflammation	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Chest Pain	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Cyst	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Malaise	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Non-cardiac chest pain	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
General disorders Oedema peripheral	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Vascular disorders Hypertension	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	50.0% 3/6 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	85.7% 6/7 • Number of events 6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Vascular disorders Flushing	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Diarrhoea	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Dry mouth	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Abdominal pain upper	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Flatulence	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Haematochezia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Gastrointestinal disorders Toothache	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Headache	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Dizziness	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Dysgeusia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Cerebral haemorrhage	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Haemorrhage intracranial	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Memory impairment	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Parosmia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Sinus headache	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Nervous system disorders Taste disorder	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Musculoskeletal and connective tissue disorders Arthralgia	42.9% 3/7 • Number of events 3 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Anxiety	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Irritability	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Libido decreased	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Mental status changes	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Psychiatric disorders Personality change	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Sinus congestion	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	33.3% 2/6 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Body tinea	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Diverticulitis	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Influenza	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Pharyngitis	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Sinusitis	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Skin infection	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Blood creatinine increased	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Infections and infestations Lipase increased	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Metabolism and nutrition disorders Decreased appetite	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Metabolism and nutrition disorders Hypercalcaemia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	28.6% 2/7 • Number of events 2 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Blood and lymphatic system disorders Lymphadenopathy	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Endocrine disorders Hyperthyroidism	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Endocrine disorders Hypothyroidism	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Injury, poisoning and procedural complications Fall	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Injury, poisoning and procedural complications Transplant failure	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Eye disorders Corneal oedema	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Eye disorders Lacrimation increased	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Eye disorders Vision blurred	14.3% 1/7 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/6 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.
Renal and urinary disorders Pollakiuria	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	16.7% 1/6 • Number of events 1 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.	0.00% 0/7 • All-cause mortality (ACM) : Up to ~22.1 months and safety: Up to ~16.5 months The all-cause mortality and safety were analyzed in all subjects who took at least one dose of study drug. The adverse event table captures treatment-emergent adverse events. In Dose Level 3, 1 of the 8 subjects did not start therapy, resulting in 7 at risk subjects.

Additional Information

Lumos Pharma

Lumos Pharma Inc. (Formerly NewLink Genetics)

Phone: 515-598-2921

Email: clinical.trials@lumos-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60