Trial Outcomes & Findings for Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma (NCT NCT03250299)

Last Updated: 2024-06-24

Results Overview

A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to BAL101553 or the combination of BAL101553 and radiation.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

Up to 10 weeks

Results posted on

2024-06-24

Participant Flow

Treatment was administered on an outpatient basis

Participant milestones

Participant milestones
Measure	BAL101553 4 mg Cohort BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg Cohort BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg Cohort BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg Cohort BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg Cohort BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
BAL101553 4 mg Cohort STARTED	5	0	0	0	0
BAL101553 4 mg Cohort COMPLETED	5	0	0	0	0
BAL101553 4 mg Cohort NOT COMPLETED	0	0	0	0	0
BAL101553 6 mg Cohort STARTED	0	5	0	0	0
BAL101553 6 mg Cohort COMPLETED	0	4	0	0	0
BAL101553 6 mg Cohort NOT COMPLETED	0	1	0	0	0
BAL101553 8 mg Cohort STARTED	0	0	7	0	0
BAL101553 8 mg Cohort COMPLETED	0	0	5	0	0
BAL101553 8 mg Cohort NOT COMPLETED	0	0	2	0	0
BAL101553 12 mg Cohort STARTED	0	0	0	5	0
BAL101553 12 mg Cohort COMPLETED	0	0	0	3	0
BAL101553 12 mg Cohort NOT COMPLETED	0	0	0	2	0
BAL101553 15 mg Cohort STARTED	0	0	0	0	4
BAL101553 15 mg Cohort COMPLETED	0	0	0	0	4
BAL101553 15 mg Cohort NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BAL101553 6 mg Cohort BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg Cohort BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg Cohort BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
BAL101553 6 mg Cohort Disease progression	1	0	0
BAL101553 8 mg Cohort Adverse Event	0	1	0
BAL101553 8 mg Cohort Withdrawal by Subject	0	1	0
BAL101553 12 mg Cohort Adverse Event	0	0	2

Baseline Characteristics

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BAL101553 4 mg Cohort n=5 Participants BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg Cohort n=5 Participants BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg Cohort n=7 Participants BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg Cohort n=5 Participants BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg Cohort n=4 Participants BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	14 Participants n=10 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	12 Participants n=10 Participants
Age, Continuous	58.2 years STANDARD_DEVIATION 10.57 • n=5 Participants	67.6 years STANDARD_DEVIATION 6.27 • n=7 Participants	57.7 years STANDARD_DEVIATION 11.22 • n=5 Participants	62.6 years STANDARD_DEVIATION 12.10 • n=4 Participants	57.8 years STANDARD_DEVIATION 13.40 • n=21 Participants	60.7 years STANDARD_DEVIATION 10.71 • n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	23 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 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	0 Participants n=21 Participants	0 Participants n=10 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	1 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	23 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	5 participants n=4 Participants	4 participants n=21 Participants	26 participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 10 weeks

Population: MTD-determining population: All patients who met any of the following criteria: * Received at least one dose of BAL101553 and has experienced a DLT; * Received ≥80% of their expected dose of BAL101553 and completed 6 weeks of combined treatment and 4 weeks of rest.

Outcome measures

Outcome measures
Measure	BAL101553 4 mg MTD-determining Cohort n=5 Participants BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg MTD-determining Cohort n=5 Participants BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg MTD-determining Cohort n=6 Participants BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg MTD-determining Cohort n=4 Participants BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg MTD-determining Cohort n=4 Participants BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Number of Patients With Dose-Limiting Toxicities (DLTs) for Each Maximal Tolerated Dose (MTD)-Determining Dose Cohort	0 participants	0 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: up to 10 weeks

Population: All patients who received at least one full or partial dose of BAL101553 and had at least one post-baseline safety assessment was included in the safety analysis populations.

Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

Outcome measures

Outcome measures
Measure	BAL101553 4 mg MTD-determining Cohort n=5 Participants BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg MTD-determining Cohort n=5 Participants BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg MTD-determining Cohort n=7 Participants BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg MTD-determining Cohort n=5 Participants BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg MTD-determining Cohort n=4 Participants BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Number of Patients With Grade 3 to Grade 5 Adverse Events (AEs) Number of patients with only unrelated CTCAE Grade 3/4/5 AEs	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Patients With Grade 3 to Grade 5 Adverse Events (AEs) Number of patients with related CTCAE Grade 3/4/5 AEs	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Patients With Grade 3 to Grade 5 Adverse Events (AEs) Number of patients without CTCAE Grade 3/4/5 AEs	3 Participants	2 Participants	5 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 to date of death - up to 1679 days (4.6 years)

Population: Full analysis population (FAP) included all patients who received at least one partial or complete dose of study drug, based on the intent-to-treat principle. In this study the FAP corresponded to the safety population.

OS was defined as the time from Day 1 dosing to the date of death. Patients who have not died at study closure were censored at the time of last known alive.

Outcome measures

Outcome measures
Measure	BAL101553 4 mg MTD-determining Cohort n=26 Participants BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg MTD-determining Cohort BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg MTD-determining Cohort BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg MTD-determining Cohort BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg MTD-determining Cohort BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Overall Survival (OS) Time	383.0 Days Interval 273.0 to 552.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to date of disease progression - 1092 days (3.0 years)

PFS was the interval between Day 1 dosing and the earliest date of progression. Progression was defined as: an increase in tumor size of more than 25% or the appearance of new lesions on MRI scans, significant clinical deterioration not attributable to causes other than the tumor, or death from any cause. Patients who have not progressed or died at study closure were censored at the time of their last assessment without progression.

Outcome measures

Outcome measures
Measure	BAL101553 4 mg MTD-determining Cohort n=26 Participants BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg MTD-determining Cohort BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg MTD-determining Cohort BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg MTD-determining Cohort BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg MTD-determining Cohort BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Progression Free Survival (PFS) Time	247.0 Days Interval 128.0 to 366.0	—	—	—	—

Adverse Events

BAL101553 4 mg Cohort

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

BAL101553 6 mg Cohort

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

BAL101553 8 mg Cohort

Serious events: 2 serious events

Other events: 7 other events

Deaths: 4 deaths

BAL101553 12 mg Cohort

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

BAL101553 15 mg Cohort

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BAL101553 4 mg Cohort n=5 participants at risk BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg Cohort n=5 participants at risk BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg Cohort n=7 participants at risk BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg Cohort n=5 participants at risk BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg Cohort n=4 participants at risk BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Nervous system disorders Aphasia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Brain oedema	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Cognitive disorder	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Dysarthria	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Facial paresis	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Headache	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Hydrocephalus	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Lethargy	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Seizure	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Constipation	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Bacteraemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Encephalitis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Peritonitis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Sepsis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Vascular disorders Embolism	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Gait disturbance	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Pyrexia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Confusional state	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began

Other adverse events

Other adverse events
Measure	BAL101553 4 mg Cohort n=5 participants at risk BAL101553 was given as an 4 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 6 mg Cohort n=5 participants at risk BAL101553 was given as an 6 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 8 mg Cohort n=7 participants at risk BAL101553 was given as an 8 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 12 mg Cohort n=5 participants at risk BAL101553 was given as an 12 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)	BAL101553 15 mg Cohort n=4 participants at risk BAL101553 was given as an 15 mg oral dose once daily (7 days per week) for 6 weeks, in combination with standard radiotherapy (RT)
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Hypoaesthesia oral	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Nausea	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Oral pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Vomiting	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Cystitis noninfective	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Haematuria	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Micturition urgency	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Nocturia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Urinary incontinence	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Urine flow decreased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Abdominal pain upper	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Anal incontinence	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Constipation	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Diarrhoea	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Dry mouth	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Alanine aminotransferase increased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	80.0% 4/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	50.0% 2/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood bilirubin increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood chloride decreased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood creatinine increased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Blood urea increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Carbon dioxide increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Haemoglobin increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Lymphocyte count decreased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Neutrophil count decreased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Platelet count decreased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	50.0% 2/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Protein total decreased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Troponin I increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	50.0% 2/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Weight decreased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations Weight increased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Investigations White blood cell count decreased	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Cardiac disorders Bradycardia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Cardiac disorders Myocarditis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Cardiac disorders Sinus tachycardia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Cardiac disorders Tachycardia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Cardiac disorders Ventricular extrasystoles	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	75.0% 3/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Aphasia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Balance disorder	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Brain oedema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Cognitive disorder	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Dizziness	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Drooling	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Dysarthria	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Dysgeusia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Dyskinesia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Extrapyramidal disorder	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Facial nerve disorder	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Facial paresis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Headache	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Hemiparesis	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Hydrocephalus	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Lethargy	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Memory impairment	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Paraesthesia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Peripheral motor neuropathy	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Peripheral sensory neuropathy	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Presyncope	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Psychomotor skills impaired	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Seizure	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Slow speech	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Tremor	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Upper motor neurone lesion	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Nervous system disorders Vasogenic cerebral oedema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Asthenopia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Dry eye	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Eyelid oedema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Ocular discomfort	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Photophobia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Vision blurred	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Eye disorders Visual impairment	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Ear and labyrinth disorders Hyperacusis	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Productive cough	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Renal and urinary disorders Urine odour abnormal	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Alopecia	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Pain of skin	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Skin fissures	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Endocrine disorders Hyperthyroidism	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Endocrine disorders Thyroid mass	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hyperkalaemia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hyperphosphataemia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	42.9% 3/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	57.1% 4/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypophagia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Mucosal infection	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Nasopharyngitis	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Sinusitis	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Infections and infestations Vaginal infection	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Injury, poisoning and procedural complications Fall	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Injury, poisoning and procedural complications Scratch	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Injury, poisoning and procedural complications Skin laceration	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Injury, poisoning and procedural complications Thermal burn	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Surgical and medical procedures Depilation	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	50.0% 2/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Vascular disorders Embolism	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Vascular disorders Hypertension	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Catheter site erythema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Chills	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Face oedema	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Fatigue	80.0% 4/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	80.0% 4/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	71.4% 5/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	75.0% 3/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Gait inability	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Non-cardiac chest pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Oedema peripheral	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Pain	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
General disorders Pyrexia	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Agitation	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Anxiety	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	40.0% 2/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Confusional state	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	60.0% 3/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Delirium	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Depression	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Disorientation	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Hallucination	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	25.0% 1/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Insomnia	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Irritability	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	28.6% 2/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Libido decreased	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	14.3% 1/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began
Psychiatric disorders Mental status changes	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	20.0% 1/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/7 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/5 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began	0.00% 0/4 • Adverse events (AEs) were collected for 10 weeks from start of treatment, All-cause Mortality monitored up to 1679 days (4.6 years) Treatment-emergent events (TEAEs) were defined as all events occurring after BAL101553 treatment began

Additional Information

Thomas Kaindl, MD, Global Medical Director

Basilea Pharmaceutica International Ltd (Basilea)

Phone: +41615671505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60