Trial Outcomes & Findings for Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097) (NCT NCT02452034)

NCT ID: NCT02452034

Last Updated: 2019-07-26

Results Overview

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC from time 0-24 hours post-dose (AUC0-24hr) of posaconazole. A non compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 118 participants
• Primary outcome timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion
• Results posted on: 2019-07-26

Participant Flow

Immunocompromised participants aged 2 to 17 years old, with neutropenia expected to last for at least 7 days following start of study treatment, were enrolled in this study.

Participant milestones

Measure	3.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Overall Study STARTED	16	21	15	17	20	29
Overall Study Treated	14	21	15	16	20	29
Overall Study COMPLETED	14	20	14	16	19	26
Overall Study NOT COMPLETED	2	1	1	1	1	3

Reasons for withdrawal

Measure	3.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Overall Study Adverse Event	0	0	0	0	0	1
Overall Study Death	0	0	0	0	1	1
Overall Study Physician Decision	0	1	1	0	0	0
Overall Study Protocol Violation	0	0	0	0	0	1
Overall Study Screen Failure	1	0	0	1	0	0
Overall Study Withdrawn by Parent/Guardian	1	0	0	0	0	0

Baseline Characteristics

Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

Baseline characteristics by cohort

Measure	3.5 mg/kg POS (2<7 Years Old) n=16 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=21 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=15 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=17 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=20 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=29 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	Total n=118 Participants Total of all reporting groups
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	11 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	18 Participants n=21 Participants	26 Participants n=10 Participants	99 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	3.9 Years STANDARD_DEVIATION 1.5 • n=5 Participants	13.9 Years STANDARD_DEVIATION 2.1 • n=7 Participants	4.1 Years STANDARD_DEVIATION 1.4 • n=5 Participants	12.5 Years STANDARD_DEVIATION 2.7 • n=4 Participants	3.9 Years STANDARD_DEVIATION 1.6 • n=21 Participants	12.0 Years STANDARD_DEVIATION 3.5 • n=10 Participants	8.9 Years STANDARD_DEVIATION 5.0 • n=115 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	50 Participants n=115 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	19 Participants n=10 Participants	68 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	12 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	19 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	18 Participants n=21 Participants	27 Participants n=10 Participants	103 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC from time 0-24 hours post-dose (AUC0-24hr) of posaconazole. A non compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS IV	17800 hr*ng/mL Geometric Coefficient of Variation 55.0	27300 hr*ng/mL Geometric Coefficient of Variation 49.7	25600 hr*ng/mL Geometric Coefficient of Variation 30.0	29800 hr*ng/mL Geometric Coefficient of Variation 42.9	31100 hr*ng/mL Geometric Coefficient of Variation 48.9	44200 hr*ng/mL Geometric Coefficient of Variation 41.5
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS PFS	12200 hr*ng/mL Geometric Coefficient of Variation 36.0	20700 hr*ng/mL Geometric Coefficient of Variation 33.8	21600 hr*ng/mL Geometric Coefficient of Variation 64.5	28700 hr*ng/mL Geometric Coefficient of Variation 33.7	23000 hr*ng/mL Geometric Coefficient of Variation 47.3	25000 hr*ng/mL Geometric Coefficient of Variation 184.3

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Maximum Plasma Concentration (Cmax) for POS IV	1590 ng/mL Geometric Coefficient of Variation 43.1	2450 ng/mL Geometric Coefficient of Variation 72.7	2320 ng/mL Geometric Coefficient of Variation 39.8	2310 ng/mL Geometric Coefficient of Variation 40.3	3060 ng/mL Geometric Coefficient of Variation 54.1	3340 ng/mL Geometric Coefficient of Variation 39.4
Maximum Plasma Concentration (Cmax) for POS PFS	884 ng/mL Geometric Coefficient of Variation 44.4	1340 ng/mL Geometric Coefficient of Variation 30.8	1550 ng/mL Geometric Coefficient of Variation 40.8	1670 ng/mL Geometric Coefficient of Variation 28.5	1510 ng/mL Geometric Coefficient of Variation 43.4	1370 ng/mL Geometric Coefficient of Variation 178.5

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmin of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Minimum Plasma Concentration (Cmin) for POS IV	400 ng/mL Geometric Coefficient of Variation 81.3	670 ng/mL Geometric Coefficient of Variation 65.1	501 ng/mL Geometric Coefficient of Variation 56.8	737 ng/mL Geometric Coefficient of Variation 66.0	626 ng/mL Geometric Coefficient of Variation 104.8	1160 ng/mL Geometric Coefficient of Variation 60.4
Minimum Plasma Concentration (Cmin) for POS PFS	254 ng/mL Geometric Coefficient of Variation 45.6	579 ng/mL Geometric Coefficient of Variation 44.9	476 ng/mL Geometric Coefficient of Variation 164.6	790 ng/mL Geometric Coefficient of Variation 48.2	542 ng/mL Geometric Coefficient of Variation 68.8	713 ng/mL Geometric Coefficient of Variation 300.6

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cavg of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Average Steady-state Plasma Concentration (Cavg) for POS IV	743 ng/mL Geometric Coefficient of Variation 55.0	1140 ng/mL Geometric Coefficient of Variation 49.7	1070 ng/mL Geometric Coefficient of Variation 30.0	1240 ng/mL Geometric Coefficient of Variation 42.9	1300 ng/mL Geometric Coefficient of Variation 48.9	1840 ng/mL Geometric Coefficient of Variation 41.5
Average Steady-state Plasma Concentration (Cavg) for POS PFS	510 ng/mL Geometric Coefficient of Variation 36.0	861 ng/mL Geometric Coefficient of Variation 33.8	901 ng/mL Geometric Coefficient of Variation 64.5	1200 ng/mL Geometric Coefficient of Variation 33.7	960 ng/mL Geometric Coefficient of Variation 47.3	1040 ng/mL Geometric Coefficient of Variation 184.3

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Tmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Time of Maximum Plasma Concentration (Tmax) for POS IV	1.78 Hours Interval 1.67 to 5.53	1.77 Hours Interval 0.0 to 3.5	1.78 Hours Interval 1.42 to 5.9	1.75 Hours Interval 1.52 to 1.8	1.75 Hours Interval 1.57 to 1.83	1.77 Hours Interval 1.33 to 6.0
Time of Maximum Plasma Concentration (Tmax) for POS PFS	3.83 Hours Interval 1.92 to 4.25	2.20 Hours Interval 1.92 to 6.03	3.82 Hours Interval 1.88 to 5.92	6.14 Hours Interval 1.98 to 7.98	4.00 Hours Interval 2.17 to 7.92	2.78 Hours Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS IV solution therapy, completed the full POS PK sampling while on POS IV solution, and met pre-specified acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL of posaconazole administered by IV. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received IV treatment.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=11 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=19 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=15 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=17 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=24 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Total Body Clearance (CL) for POS Administered by IV	3.39 L/hr Geometric Coefficient of Variation 52.8	6.64 L/hr Geometric Coefficient of Variation 38.6	2.97 L/hr Geometric Coefficient of Variation 36.2	6.69 L/hr Geometric Coefficient of Variation 37.3	3.27 L/hr Geometric Coefficient of Variation 49.3	4.76 L/hr Geometric Coefficient of Variation 55.7

PRIMARY outcome

Timeframe: Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion

Population: All treated participants who received at least 7 days of POS PFS therapy, completed the full POS PK sampling while on POS PFS, and met pre-specified acceptability criteria.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL/F of posaconazole administered by PFS. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received PFS treatment.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=5 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=10 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=8 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=8 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=7 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=12 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Apparent Total Body Clearance (CL/F) for POS Administered by PFS	4.97 L/hr Geometric Coefficient of Variation 29.1	7.67 L/hr Geometric Coefficient of Variation 39.9	3.49 L/hr Geometric Coefficient of Variation 59.1	7.84 L/hr Geometric Coefficient of Variation 49.4	4.60 L/hr Geometric Coefficient of Variation 35.2	8.39 L/hr Geometric Coefficient of Variation 190.3

SECONDARY outcome

Timeframe: 14 days after end of treatment (Up to 42 days)

Population: All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=21 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=15 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=16 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=20 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=29 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Number of Participants With an Adverse Event (AE)	13 Participants	21 Participants	15 Participants	16 Participants	19 Participants	29 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Measure	3.5 mg/kg POS (2<7 Years Old) n=14 Participants Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=21 Participants Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=15 Participants Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=16 Participants Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (2<7 Years Old) n=20 Participants Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6 mg/kg POS (7-17 Years Old) n=29 Participants Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE)	3 Participants	3 Participants	0 Participants	2 Participants	4 Participants	6 Participants

Adverse Events

3.5 mg/kg POS (2<7 Years Old)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 1 deaths

3.5 mg/kg POS (7-17 Years Old)

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

4.5 mg/kg POS (2<7 Years Old)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

4.5 mg/kg POS (7-17 Years Old)

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

6.0 mg/kg POS (2<7 Years Old)

Serious events: 3 serious events

Other events: 19 other events

Deaths: 1 deaths

6.0 mg/kg POS (7-17 Years Old)

Serious events: 8 serious events

Other events: 29 other events

Deaths: 2 deaths

Serious adverse events

Measure	3.5 mg/kg POS (2<7 Years Old) n=14 participants at risk Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=21 participants at risk Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=15 participants at risk Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=16 participants at risk Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6.0 mg/kg POS (2<7 Years Old) n=20 participants at risk Children 2 to less than 7 years of age received POS at 6 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6.0 mg/kg POS (7-17 Years Old) n=29 participants at risk Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Cardiac failure	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Cardiomyopathy	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Abdominal pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Stomatitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Vomiting	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Pyrexia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Hepatobiliary disorders Hepatic lesion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Drug hypersensitivity	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Engraftment syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Transplant rejection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Adenovirus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Device related infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Clostridium difficile colitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Cystitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Enterobacter infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Fungal infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Herpes zoster	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Parainfluenzae virus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Pneumonia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Pneumonia viral	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Streptococcal sepsis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Systemic mycosis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Urinary tract infection viral	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hyponatraemia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Presyncope	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Acute kidney injury	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Renal failure	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Capillary leak syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Hypertension	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Thrombophlebitis superficial	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Venoocclusive disease	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.

Other adverse events

Measure	3.5 mg/kg POS (2<7 Years Old) n=14 participants at risk Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	3.5 mg/kg POS (7-17 Years Old) n=21 participants at risk Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (2<7 Years Old) n=15 participants at risk Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	4.5 mg/kg POS (7-17 Years Old) n=16 participants at risk Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6.0 mg/kg POS (2<7 Years Old) n=20 participants at risk Children 2 to less than 7 years of age received POS at 6 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.	6.0 mg/kg POS (7-17 Years Old) n=29 participants at risk Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV.
Eye disorders Eye haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Eye irritation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Eye pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Eyelid oedema	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Ocular hyperaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Periorbital oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Photophobia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Vision blurred	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Visual impairment	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Abdominal distension	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	37.5% 6/16 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	17.2% 5/29 • Number of events 7 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Anal fissure	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Anal inflammation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Anorectal disorder	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Ascites	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Colitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Constipation	21.4% 3/14 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.8% 4/29 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Diarrhoea	35.7% 5/14 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	33.3% 5/15 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	25.0% 4/16 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	25.0% 5/20 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.8% 4/29 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Dyspepsia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Dysphagia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Faeces hard	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Proctitis herpes	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Gingival bleeding	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Gingival pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Klebsiella bacteraemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Glossodynia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Haematemesis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Haematochezia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Haemorrhoids	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Lip dry	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Lip pruritus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Loose tooth	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Mouth ulceration	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	19.0% 4/21 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	24.1% 7/29 • Number of events 9 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Odynophagia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Oesophagitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Oral disorder	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Oral mucosal exfoliation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Oral pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Scalloped tongue	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Stomatitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	15.0% 3/20 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.7% 6/29 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Subileus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Tooth loss	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Toothache	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Gastrointestinal disorders Vomiting	28.6% 4/14 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	28.6% 6/21 • Number of events 9 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	37.5% 6/16 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	30.0% 6/20 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.7% 6/29 • Number of events 13 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Axillary pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Catheter site erythema	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Catheter site haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Catheter site oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Catheter site pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Catheter site swelling	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Chills	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Face oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders General physical health deterioration	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Generalised oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Granuloma	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Infusion site erythema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Malaise	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Mucosal inflammation	21.4% 3/14 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	42.9% 9/21 • Number of events 10 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	33.3% 5/15 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	25.0% 4/16 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	25.0% 5/20 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.7% 6/29 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Oedema peripheral	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Pyrexia	57.1% 8/14 • Number of events 13 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	42.9% 9/21 • Number of events 11 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	40.0% 6/15 • Number of events 9 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	62.5% 10/16 • Number of events 13 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	40.0% 8/20 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	27.6% 8/29 • Number of events 12 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
General disorders Systemic inflammatory response syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Hepatobiliary disorders Hepatomegaly	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Hepatobiliary disorders Jaundice	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Drug hypersensitivity	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Engraftment syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Graft versus host disease	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Graft versus host disease in liver	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Graft versus host disease in skin	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Immunodeficiency	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Immunodeficiency common variable	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Immune system disorders Serum sickness	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Adenovirus infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations BK virus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Bacteraemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Bacterial infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Bronchitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Clostridial infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Clostridium difficile colitis	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Buttock injury	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Clostridium difficile infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Conjunctivitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Corona virus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Cystitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Cytomegalovirus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.0% 3/15 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Device related infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Ear infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Endocarditis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Enterobacter bacteraemia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Epstein-Barr virus infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Escherichia sepsis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Gingivitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Hepatitis E	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Human bocavirus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Klebsiella infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Localised infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Lung infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Mucosal infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Nasopharyngitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Oral herpes	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Paronychia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Pneumonia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Pneumonia parainfluenzae viral	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Respiratory tract infection	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Rhinitis	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Rhinovirus infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Sepsis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Staphylococcal infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Staphylococcal sepsis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Fluid retention	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Viraemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Viral infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Accidental overdose	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Allergic transfusion reaction	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Head injury	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Injury, poisoning and procedural complications Scratch	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Alanine aminotransferase increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	17.2% 5/29 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood potassium increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Aspartate aminotransferase increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	17.2% 5/29 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations BK polyomavirus test positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Bacterial test positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood albumin decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood alkaline phosphatase increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood bilirubin increased	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood calcium decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood creatinine increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood culture positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood immunoglobulin G decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood lactate dehydrogenase increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood magnesium decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood phosphorus decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Electrocardiogram QT prolonged	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood potassium decreased	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood urea increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood uric acid decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Blood uric acid increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Breath sounds abnormal	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations C-reactive protein increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Cytomegalovirus test positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Drug level increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Fibrin D dimer increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Fluid balance positive	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Neutrophil count decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Oxygen saturation decreased	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Platelet count decreased	7.1% 1/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Pulmonary arterial pressure increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Red blood cells urine positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Transaminases increased	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Viral test positive	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Vitamin D decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations Weight increased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Investigations White blood cell count decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Decreased appetite	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	19.0% 4/21 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.0% 3/15 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	15.0% 3/20 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.8% 4/29 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Fluid intake reduced	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	14.3% 3/21 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	35.0% 7/20 • Number of events 7 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	24.1% 7/29 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Leukopenia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Pancytopenia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Neutropenia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Bradycardia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Pericardial effusion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Sinus bradycardia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Sinus tachycardia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Ear and labyrinth disorders Ear pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Ear and labyrinth disorders Tinnitus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Ear and labyrinth disorders Vertigo	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Endocrine disorders Cushingoid	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Conjunctival haemorrhage	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Eye disorders Dry eye	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hyperglycaemia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hyperkalaemia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Hypotonia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypertriglyceridaemia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypochloraemia	7.1% 1/14 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypoglycaemia	7.1% 1/14 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypokalaemia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	15.0% 3/20 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	24.1% 7/29 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypomagnesaemia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.8% 4/29 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hyponatraemia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypophagia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	15.0% 3/20 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Magnesium deficiency	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Metabolism and nutrition disorders Vitamin D deficiency	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	18.8% 3/16 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Dizziness	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	19.0% 4/21 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	31.2% 5/16 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	17.2% 5/29 • Number of events 7 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Hypoaesthesia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Intention tremor	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Myoclonus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Opisthotonus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Paraesthesia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Posterior reversible encephalopathy syndrome	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Nervous system disorders Somnolence	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Agitation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Depressed mood	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Depression	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Psychiatric disorders Irritability	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Acute kidney injury	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Dysuria	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Glycosuria	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Haematuria	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Micturition urgency	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Nephropathy toxic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Proteinuria	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Renal and urinary disorders Urinary retention	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Menorrhagia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Perineal erythema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Perineal pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Acne	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Testicular oedema	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	26.7% 4/15 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 2/14 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	31.2% 5/16 • Number of events 8 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Lung infiltration	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Respiratory, thoracic and mediastinal disorders Tonsillar exudate	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Alopecia	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Blister	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dermatitis diaper	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Erythema	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	15.0% 3/20 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Macule	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Palmar erythema	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Papule	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Petechiae	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	31.2% 5/16 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.0% 4/20 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	24.1% 7/29 • Number of events 7 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Rash	14.3% 2/14 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	19.0% 4/21 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.0% 3/15 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	20.0% 4/20 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.3% 3/29 • Number of events 3 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	10.0% 2/20 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin lesion	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Skin ulcer	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Swelling face	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Capillary leak syndrome	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Flushing	7.1% 1/14 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Haematoma	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	4.8% 1/21 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Hyperaemia	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Hypertension	35.7% 5/14 • Number of events 5 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	9.5% 2/21 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.3% 2/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	30.0% 6/20 • Number of events 6 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	13.8% 4/29 • Number of events 4 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Hypotension	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	12.5% 2/16 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	5.0% 1/20 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.9% 2/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Pallor	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Phlebitis	0.00% 0/14 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/15 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.2% 1/16 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/29 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
Vascular disorders Venoocclusive disease	14.3% 2/14 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/21 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	6.7% 1/15 • Number of events 1 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/16 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	0.00% 0/20 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.	3.4% 1/29 • Number of events 2 • AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110. All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER