Trial Outcomes & Findings for Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) (NCT NCT03224819)

NCT ID: NCT03224819

Last Updated: 2023-09-01

Results Overview

The severity of each adverse event (AE) was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening and Grade 5 = death due to AE. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 46 participants
• Primary outcome timeframe: From first dose of study drug until the end of study; median (minimum, maximum) duration was 1.22 (0.10, 5.98) months.
• Results posted on: 2023-09-01

Participant Flow

This study was conducted at 7 centers in United States, Australia, and Germany.

Participant milestones

Measure	Schedule A Cohort 1: 0.05 µg Emerfetamab Participants received 0.05 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Overall Study STARTED	1	1	3	3	3	3	3	3	4	6	4	4	5	3
Overall Study COMPLETED	1	0	3	2	2	1	2	1	2	4	3	2	3	3
Overall Study NOT COMPLETED	0	1	0	1	1	2	1	2	2	2	1	2	2	0

Reasons for withdrawal

Measure	Schedule A Cohort 1: 0.05 µg Emerfetamab Participants received 0.05 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Overall Study Sponsor Decision	0	0	0	1	1	2	1	1	1	2	1	1	1	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Death	0	1	0	0	0	0	0	1	0	0	0	1	0	0

Baseline Characteristics

Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Schedule A Cohort 1: 0.05 µg Emerfetamab n=1 Participants Participants received 0.05 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Total n=46 Participants Total of all reporting groups
Age, Continuous	25.0 years n=5 Participants	61.0 years n=7 Participants	49.3 years STANDARD_DEVIATION 16.3 • n=5 Participants	69.3 years STANDARD_DEVIATION 8.1 • n=4 Participants	60.3 years STANDARD_DEVIATION 23.9 • n=21 Participants	60.7 years STANDARD_DEVIATION 18.9 • n=8 Participants	73.7 years STANDARD_DEVIATION 2.1 • n=8 Participants	45.7 years STANDARD_DEVIATION 14.6 • n=24 Participants	68.8 years STANDARD_DEVIATION 11.8 • n=42 Participants	71.8 years STANDARD_DEVIATION 7.0 • n=42 Participants	57.5 years STANDARD_DEVIATION 11.6 • n=42 Participants	72.0 years STANDARD_DEVIATION 5.1 • n=42 Participants	61.4 years STANDARD_DEVIATION 18.2 • n=36 Participants	54.0 years STANDARD_DEVIATION 7.5 • n=36 Participants	62.1 years STANDARD_DEVIATION 15.1 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=36 Participants	2 Participants n=36 Participants	23 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=36 Participants	1 Participants n=36 Participants	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	5 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	2 Participants n=36 Participants	41 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized Black (or African American)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	3 Participants n=36 Participants	41 Participants n=24 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until the end of study; median (minimum, maximum) duration was 1.22 (0.10, 5.98) months.

Population: All enrolled participants who received at least 1 dose of study drug.

The severity of each adverse event (AE) was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening and Grade 5 = death due to AE.

A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:

• fatal
• life threatening
• required in patient hospitalization or prolongation of existing hospitalization
• resulted in persistent or significant disability/incapacity
• congenital anomaly/birth defect
• other medically important serious event.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Number of Participants With Treatment-emergent Adverse Events Any treatment emergent adverse event (TEAE)	1 Participants	1 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants	6 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE Grade ≥ 2	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants	4 Participants	6 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE Grade ≥ 3	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	3 Participants	5 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE Grade ≥ 4	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events SAE leading to interruption of study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events Serious adverse events (SAE)	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants	5 Participants	3 Participants	4 Participants	1 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to discontinuation of study drug	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events SAE leading to discontinuation of study drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to interruption of study drug	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events Fatal adverse events	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment related TEAEs	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants	1 Participants	3 Participants	3 Participants	4 Participants	6 Participants	4 Participants	4 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Schedule A: From the start of the first infusion on day 1 until day 14. Schedule B: From the start of the first infusion on day 1 to day 28.

Population: Enrolled participants who received at least 1 dose of study drug who received the minimum cycle 1 doses planned for the respective cohort: Schedule A: 2 doses within 14-day window; Schedule B: completed ≥ 70% of the planned target doses within 28-day window.

A DLT was defined as any of the events described below occurring in a participant during the DLT window, unless clearly attributable to causes other than emerfetamab:

• Any treatment-related death;
• Grade 4 neutropenia persisting at 42 days after the last infusion in treatment cycle 1;
• Grade 3-5 non-hematologic toxicity not clearly resulting from the underlying leukemia with a few protocol-specified exceptions;
• Grade 2 or 3 cytokine release syndrome (CRS) meeting any of the criteria listed below:

• Grade 2 CRS that does not resolve, with or without intervention to Grade 1 within 7 days;
• Grade 3 CRS that does not resolve, with or without intervention to Grade 2 within 5 days, or grade 1 within 7 days;
• Grade 3 CRS reported at the initial dose;
• Two separate grade 3 CRS events;
• Grade 4 CRS occurring during treatment.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=3 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Number of Participants With Dose-limiting Toxicities (DLT) Any dose-limiting toxicity	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Alanine aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Acute kidney injury	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Bone pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Cytokine release syndrome	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Gamma-glutamyltransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Dose-limiting Toxicities (DLT) Lipase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose and at 1, 6, 24, and 48 hours after the start of infusion, and day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantitation (LLOQ; 0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Maximum Observed Concentration (Cmax) of Emerfetamab Day 1	0.00979 ng/mL	0.038 ng/mL	0.0255 ng/mL Standard Deviation 0.0335	0.0463 ng/mL Standard Deviation 0.0436	0.347 ng/mL Standard Deviation 0.133	1.04 ng/mL Standard Deviation 1.43	0.960 ng/mL Standard Deviation 1.10	1.12 ng/mL Standard Deviation 1.12	2.16 ng/mL Standard Deviation 1.78	3.15 ng/mL Standard Deviation 1.90	4.65 ng/mL Standard Deviation 1.64	1.84 ng/mL Standard Deviation 1.08	—	—
Schedule A: Maximum Observed Concentration (Cmax) of Emerfetamab Day 5	0.011 ng/mL	0.027 ng/mL	0.0448 ng/mL Standard Deviation 0.00672	0.0587 ng/mL Standard Deviation 0.0517	0.264 ng/mL Standard Deviation NA Not calculated when N=2	0.731 ng/mL Standard Deviation 0.529	0.961 ng/mL Standard Deviation 1.30	1.23 ng/mL Standard Deviation 0.586	2.01 ng/mL Standard Deviation 0.926	3.14 ng/mL Standard Deviation 1.80	5.07 ng/mL Standard Deviation 2.53	3.29 ng/mL Standard Deviation 0.484	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose and at 1, 6, 24, and 48 hours after the start of infusion, and day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 pharmacokinetic (PK) sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Time to Maximum Observed Concentration (Tmax) of Emerfetamab Day 1	0.53 hours	0.50 hours	0.62 hours Interval 0.38 to 0.75	0.48 hours Interval 0.0 to 0.75	0.5 hours Interval 0.5 to 2.3	0.50 hours Interval 0.35 to 1.8	2.0 hours Interval 0.48 to 6.0	1.0 hours Interval 0.52 to 1.2	1.0 hours Interval 1.0 to 1.2	1.1 hours Interval 0.92 to 2.1	1.1 hours Interval 1.0 to 1.3	0.97 hours Interval 0.62 to 1.2	—	—
Schedule A: Time to Maximum Observed Concentration (Tmax) of Emerfetamab Day 5	4.08 hours	2 hours	2.3 hours Interval 1.9 to 2.3	2.1 hours Interval 2.0 to 2.1	1.9 hours Interval 1.7 to 2.0	2.0 hours Interval 1.9 to 2.0	1.1 hours Interval 1.0 to 24.0	1.1 hours Interval 1.1 to 1.8	1.0 hours Interval 0.95 to 1.1	1.1 hours Interval 0.98 to 6.1	1.0 hours Interval 0.93 to 1.1	1.1 hours Interval 0.98 to 1.5	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose and at 1, 6, 24, 48, and 96 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The area under the curve (AUC) from time zero to 96 hours postdose was calculated using the linear trapezoidal method.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=2 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=3 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Area Under the Concentration-time Curve From Time Zero to 96 Hours Post-dose (AUC0-96) on Day 1 for Emerfetamab	0.222 hr*ng/mL	0.84 hr*ng/mL	0.659 hr*ng/mL Standard Deviation 0.664	1.03 hr*ng/mL Standard Deviation NA Not calculated when N=2	5.37 hr*ng/mL Standard Deviation 1.23	12.0 hr*ng/mL Standard Deviation 8.79	13.5 hr*ng/mL Standard Deviation 10.4	16.5 hr*ng/mL Standard Deviation 13.0	22.4 hr*ng/mL Standard Deviation 9.66	34.4 hr*ng/mL Standard Deviation 11.7	62.4 hr*ng/mL Standard Deviation 10.4	18.3 hr*ng/mL Standard Deviation 5.02	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Non-compartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The area under the concentration-time curve from time 0 relative to the start of the IV infusion to the last quantifiable concentration was estimated using the linear trapezoidal method.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=2 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=3 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for Emerfetamab	0.302 hr*ng/mL	0.745 hr*ng/mL	1.38 hr*ng/mL Standard Deviation 0.406	1.01 hr*ng/mL Standard Deviation 0.855	5.93 hr*ng/mL Standard Deviation NA Not calculated for N = 2	22.7 hr*ng/mL Standard Deviation 24.2	14.4 hr*ng/mL Standard Deviation 9.69	19.3 hr*ng/mL Standard Deviation 8.95	27.1 hr*ng/mL Standard Deviation 12.9	35.3 hr*ng/mL Standard Deviation 9.13	56.8 hr*ng/mL Standard Deviation 31.3	35.7 hr*ng/mL Standard Deviation 7.85	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Non-compartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The area under the concentration-time curve from time 0 relative to the start of the IV infusion to infinity was estimated using the linear trapezoidal method.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=2 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=2 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=2 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=3 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) for Emerfetamab	—	0.784 hr*ng/mL	1.56 hr*ng/mL Standard Deviation 0.394	1.56 hr*ng/mL Standard Deviation NA Not calculated when N=2	6.16 hr*ng/mL Standard Deviation NA Not calculated when N=2	23.6 hr*ng/mL Standard Deviation 25.1	15.3 hr*ng/mL Standard Deviation 10.8	16.3 hr*ng/mL Standard Deviation NA Not calculated when N=2	28.6 hr*ng/mL Standard Deviation 13.1	36.8 hr*ng/mL Standard Deviation 9.04	61.0 hr*ng/mL Standard Deviation 36.5	38.3 hr*ng/mL Standard Deviation 10.9	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose and at 1, 6, 24, and 48 hours after the start of infusion, and day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Non-compartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The AUC total was calculated as the sum of AUC0-96hr following the Day 1 dose and AUCinf following the Day 5 dose.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=2 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=2 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=2 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=3 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=3 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: AUC Total for Emerfetamab	—	1.62 hr*ng/mL	2.22 hr*ng/mL Standard Deviation 1.05	2.59 hr*ng/mL Standard Deviation NA Not calculated when N = 2	10.8 hr*ng/mL Standard Deviation NA Not calculated when N = 2	35.6 hr*ng/mL Standard Deviation 26.4	28.8 hr*ng/mL Standard Deviation 16.4	25.5 hr*ng/mL Standard Deviation NA Not calculated when N = 2	51.1 hr*ng/mL Standard Deviation 16.6	71.2 hr*ng/mL Standard Deviation 18.9	126 hr*ng/mL Standard Deviation 42.7	51.2 hr*ng/mL Standard Deviation 6.39	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Non-compartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Terminal half-life (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=2 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=2 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=2 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=3 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Terminal Half-life (T1/2,z) of Emerfetamab	—	16.3 hours	35.1 hours Standard Deviation 21.7	14.3 hours Standard Deviation NA Not calculated when N = 2	35.2 hours Standard Deviation NA Not calculated when N = 2	54.7 hours Standard Deviation 20.5	55.8 hours Standard Deviation 38.3	46.5 hours Standard Deviation NA Not calculated when N = 2	36.5 hours Standard Deviation 13.3	41.7 hours Standard Deviation 17.8	36.8 hours Standard Deviation 22.4	40.6 hours Standard Deviation 15.2	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 5 at predose and 1, 6, 12, 24, 48, 72, and 312 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Non-compartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Clearance was calculated as Dose/λz*AUCinf.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=2 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=2 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=2 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=3 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule A: Clearance (CL) of Emerfetamab	—	191 mL/hr	300 mL/hr Standard Deviation 66.2	963 mL/hr Standard Deviation NA Not calculated when N = 2	742 mL/hr Standard Deviation NA Not calculated when N = 2	584 mL/hr Standard Deviation 434	897 mL/hr Standard Deviation 718	1330 mL/hr Standard Deviation NA Not calculated when N = 2	1420 mL/hr Standard Deviation 474	2070 mL/hr Standard Deviation 611	2210 mL/hr Standard Deviation 1030	1980 mL/hr Standard Deviation 459	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=3 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Maximum Observed Concentration (Cmax) of Emerfetamab	4.07 ng/mL	4.71 ng/mL Standard Deviation 2.01	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=3 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Time to Maximum Observed Concentration (Tmax) of Emerfetamab	5.5 hours	1.0 hours Interval 1.0 to 6.3	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The area under the concentration-time curve from time 0 relative to the start of the IV infusion to the last quantifiable concentration was estimated using the linear trapezoidal method.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=3 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for Emerfetamab	97.2 hr*ng/mL	42.9 hr*ng/mL Standard Deviation 20.4	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter. No participants in Schedule B cohort 2 had data available for calculation of AUCinf.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

The area under the concentration-time curve from time 0 relative to the start of the IV infusion to infinity was estimated using the linear trapezoidal method.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) for Emerfetamab	106 hr*ng/mL	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter. No participants in Schedule B cohort 2 had data available for calculation of T1/2,z.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Terminal Half-life (T1/2,z) of Emerfetamab	30.5 hours	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 day 14 at predose and 1, 6, 12, 24, 48, 72, 96, and 120 hours after the start of infusion.

Population: Participants who received at least 1 dose of study drug, had at least 1 PK sample collected, with enough data for calculation of the PK parameter. No participants in Schedule B cohort 2 had data available for calculation of clearance.

Serum concentrations of emerfetamab were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (0.0015 ng/mL) were set to zero before data analysis.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Schedule B: Clearance of Emerfetamab	0.677 mL/hr	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Disease response was assessed on day 14 of every treatment cycle and at the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Population: All participants who received at least one dose of study drug.

Disease response was based upon review of cytogenetics, bone marrow (BM) aspirates/biopsies, and peripheral blood count. Response rate is defined as the percentage of participants with a best overall response of complete remission (CR), CR with incomplete recovery (CRi) or morphologic leukemia-free state (MLFS) according to Revised International Working Group (IWG) response criteria, or CR with partial hematologic recovery (CRh*).

CR: BM blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) > 1.0 x 10^9/L; platelet count > 100 x 10^9/L; independence of red cell transfusions.

CRi: All CR criteria except residual neutropenia or thrombocytopenia. MLFS: BM blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.

CRh*: < 5% blasts in BM; no evidence of disease; partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl; no extramedullary disease.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Response Rate	0.0 percentage of participants Interval 0.0 to 90.0	0.0 percentage of participants Interval 0.0 to 90.0	0.0 percentage of participants Interval 0.0 to 53.6	0.0 percentage of participants Interval 0.0 to 53.6	0.0 percentage of participants Interval 0.0 to 53.6	0.0 percentage of participants Interval 0.0 to 53.6	0.0 percentage of participants Interval 0.0 to 53.6	0.0 percentage of participants Interval 0.0 to 53.6	25.0 percentage of participants Interval 2.6 to 68.0	0.0 percentage of participants Interval 0.0 to 31.9	0.0 percentage of participants Interval 0.0 to 43.8	0.0 percentage of participants Interval 0.0 to 43.8	40.0 percentage of participants Interval 11.2 to 75.3	0.0 percentage of participants Interval 0.0 to 53.6

SECONDARY outcome

Timeframe: Disease response was assessed on day 14 of every treatment cycle and at the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Population: All participants who received at least one dose of study drug with a best response of CR, CRi, MLFS, or CRh\*

Duration of response is defined as the interval from the date of the first disease assessment indicating an overall response to the first documented relapse or death due to any cause, whichever occurred first.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=1 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=2 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Duration of Response	—	—	—	—	—	—	—	—	22 days	—	—	—	21 days Interval 1.0 to 41.0	—

SECONDARY outcome

Timeframe: Disease response was assessed on day 14 of every treatment cycle and at the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Population: All participants who received at least one dose of study drug with a best response of CR, CRi, MLFS, or CRh\*

Time to response is defined as the interval from the first administration of study drug to the first documentation of response. Time to response was evaluated only for participants who achieved a response.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=1 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=2 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Time to Response	—	—	—	—	—	—	—	—	42 days	—	—	—	22 days Interval 14.0 to 30.0	—

SECONDARY outcome

Timeframe: Disease response was assessed on day 14 of every treatment cycle and at the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Population: All participants who received at least one dose of study drug.

Time to progression (event-free survival) is defined as the interval from first administration of study drug to the earliest of date of treatment failure, relapse for responders, or death due to any cause. For non-responders, the event date for treatment failure was assigned as the date of first administration of study drug.

Outcome measures

Measure	Schedule B Cohort 1: 72 µg Emerfetamab n=1 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 Participants Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 Participants Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 Participants Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 Participants Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 Participants Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 Participants Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 Participants Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 Participants Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 Participants Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 Participants Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 Participants Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Time to Progression	1 days	1 days	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 63.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 1.0	1 days Interval 1.0 to 11.0	1 days Interval 1.0 to 70.0	1 days Interval 1.0 to 1.0

Adverse Events

Schedule A Cohort 1: 0.05 µg Emerfetamab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Schedule A Cohort 2: 0.15 µg Emerfetamab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Schedule A Cohort 3: 0.45 µg Emerfetamab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Schedule A Cohort 4: 1.5 µg Emerfetamab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A Cohort 5: 4.5 µg Emerfetamab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A Cohort 6: 7 µg Emerfetamab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A Cohort 7: 9 µg Emerfetamab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule A Cohort 8: 18 µg Emerfetamab

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Schedule A Cohort 9: 36 µg Emerfetamab

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Schedule A Cohort 10: 72 µg Emerfetamab

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule A Cohort 11: 110 µg Emerfetamab

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Schedule A Cohort 12: 36/72 µg Emerfetamab

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Schedule B Cohort 1: 72 µg Emerfetamab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Schedule B Cohort 2: 110 µg Emerfetamab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Schedule A Cohort 1: 0.05 µg Emerfetamab n=1 participants at risk Participants received 0.05 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 participants at risk Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 participants at risk Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 participants at risk Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 participants at risk Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 participants at risk Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 participants at risk Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 participants at risk Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 participants at risk Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 participants at risk Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 participants at risk Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 participants at risk Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 participants at risk Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 participants at risk Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Multiple organ dysfunction syndrome	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Physical deconditioning	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Pyrexia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Bacteraemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Perirectal abscess	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Pneumonia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Pneumonia fungal	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Pneumonia viral	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Sepsis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Septic shock	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Tonsillitis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Urinary tract infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Vascular device infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Platelet count decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations White blood cell count decreased	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations White blood cell count increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Other adverse events

Measure	Schedule A Cohort 1: 0.05 µg Emerfetamab n=1 participants at risk Participants received 0.05 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 2: 0.15 µg Emerfetamab n=1 participants at risk Participants received 0.15 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 3: 0.45 µg Emerfetamab n=3 participants at risk Participants received 0.45 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 4: 1.5 µg Emerfetamab n=3 participants at risk Participants received 1.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 5: 4.5 µg Emerfetamab n=3 participants at risk Participants received 4.5 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 6: 7 µg Emerfetamab n=3 participants at risk Participants received 7 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 7: 9 µg Emerfetamab n=3 participants at risk Participants received 9 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 8: 18 µg Emerfetamab n=3 participants at risk Participants received 18 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 9: 36 µg Emerfetamab n=4 participants at risk Participants received 36 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 10: 72 µg Emerfetamab n=6 participants at risk Participants received 72 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 11: 110 µg Emerfetamab n=4 participants at risk Participants received 110 µg emerfetamab intravenously on day 1 and day 5 of each 14-day cycle for up to 12 total treatment cycles.	Schedule A Cohort 12: 36/72 µg Emerfetamab n=4 participants at risk Participants received 36 µg emerfetamab intravenously on day 1 and 72 µg emerfetamab on day 5 and thereafter of each 14-day cycle for up to 12 total treatment cycles.	Schedule B Cohort 1: 72 µg Emerfetamab n=5 participants at risk Participants received 72 µg emerfetamab intravenously once a day (QD) from days 1 to 14 for the first treatment cycle then on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.	Schedule B Cohort 2: 110 µg Emerfetamab n=3 participants at risk Participants received 72 µg emerfetamab intravenously on day 1 and day 2 then 110 µg emerfetamab once a day from days 3 to 14 in the first treatment cycle, then 110 µg emerfetamab on day 1, day 4, day 8, and day 11 of each subsequent 14-day cycle for up to a total of 12 cycles.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Constipation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Amylase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 4/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Decreased appetite	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Anxiety	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypocalcaemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypophosphataemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 3/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Groin pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Musculoskeletal and connective tissue disorders Soft tissue mass	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Ataxia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Dizziness	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Headache	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Lethargy	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Memory impairment	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Somnolence	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Speech disorder	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Nervous system disorders Tremor	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Agitation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Confusional state	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Hallucination	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Insomnia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Psychiatric disorders Restlessness	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Dysuria	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Haematuria	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Leukocyturia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Proteinuria	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Renal impairment	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 4/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Epistaxis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Tachypnoea	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Hyperhidrosis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Rash erythematous	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Haematoma	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Hypertension	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Hypotension	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Lymphoedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Orthostatic hypotension	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Vascular disorders Thrombosis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Haemolysis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Hypofibrinogenaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Intravascular haemolysis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Leukocytosis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Cardiac disorders Pericardial effusion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Cardiac disorders Tachycardia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Cardiac disorders Ventricular arrhythmia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Ear and labyrinth disorders Hypoacusis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Endocrine disorders Adrenal insufficiency	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Conjunctival haemorrhage	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Dry eye	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Eye irritation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Eye pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Iridocyclitis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Eye disorders Vision blurred	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Anal fissure	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Anal incontinence	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Ascites	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Colitis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Diverticular perforation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Dysphagia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Flatulence	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Nausea	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Oral disorder	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Oral pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Proctalgia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Retching	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Salivary hypersecretion	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Stomatitis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Toothache	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Gastrointestinal disorders Vomiting	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Asthenia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Catheter site pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Chest discomfort	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Chest pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Chills	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Fatigue	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Gait disturbance	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Generalised oedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Localised oedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Mucosal inflammation	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Non-cardiac chest pain	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Oedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Oedema peripheral	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 3/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
General disorders Pyrexia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Hepatobiliary disorders Gallbladder oedema	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Hepatobiliary disorders Hepatic cyst	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Hepatobiliary disorders Hepatomegaly	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 3/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	83.3% 5/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 5/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 3/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Immune system disorders Seasonal allergy	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Abscess limb	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Bacteriuria	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Cellulitis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Clostridium difficile colitis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Cytomegalovirus colitis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Cytomegalovirus infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Device related infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Enterocolitis infectious	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Gastrointestinal infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Genitourinary tract infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Infusion site infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Pharyngitis	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Pneumonia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Soft tissue infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Infections and infestations Urinary tract infection	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Genital contusion	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Procedural pain	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Skin abrasion	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Skin wound	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Activated partial thromboplastin time	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Activated partial thromboplastin time shortened	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Alanine aminotransferase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 2/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	75.0% 3/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blast cell count increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood bilirubin increased	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood calcium decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood creatinine increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood fibrinogen decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood lactic acid increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood phosphorus increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood potassium decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Blood urea increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations C-reactive protein increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Glomerular filtration rate decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Hepatic enzyme abnormal	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations International normalised ratio increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Lipase increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Liver function test abnormal	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Lymphocyte count decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	66.7% 2/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Neutrophil count decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Platelet count decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Protein total decreased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Serum ferritin increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Troponin I increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Troponin increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations Weight decreased	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations White blood cell count decreased	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Investigations White blood cell count increased	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Acidosis	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	50.0% 2/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypermagnesaemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hyperphosphataemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hyperphosphatasaemia	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	20.0% 1/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypervolaemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 1/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/1 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	33.3% 1/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	16.7% 1/6 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	25.0% 1/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/4 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	40.0% 2/5 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.	0.00% 0/3 • All-cause mortality is reported from enrollment until end of study; median (min, max) time on study was 1.31 (0.20, 5.98) months. Adverse events are reported from first dose of study drug until the end of study; median (min, max) duration was 1.22 (0.10, 5.98) months.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER